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August 2016

76th FIP World Congress of Pharmacy and Pharmaceutical Sciences 2016

August 28 - September 1, 2016

Hilton Hotel Buenos Aires, Buenos Aires, Non-U.S., Argentina

Each year the international FIP Congress is organized in a different city in the world together with one of FIP's Member Associations. Around 3000 Pharmacists and Pharmaceutical scientists from over 100 countries come together to network, learn, discuss and take part in an excellent social program. Topic A: Social determinants of health Topic B: Novel tools for prevention and treatment Topic C: Diagnostics and adherence – putting progress into collaborative practice. Topic D: Sustainable and affordable global health Topic E: Miscellaneous For sponsorship and exhibition opportunities, please get in touch.

7th World Congress on Bioavailability & Bioequivalence: BA/BE Studies Summit

August 29-31, 2016

Hilton Atlanta Airport, Atlanta, GA, USA

BABE 2016 Conference invites all the participants across the globe to attend the " 7th World Congress on Bioavailability & Bioequivalence: BA/BE Studies Summit.”  It is a scientific platform to meet fellow key decision makers all-around the Academic Institutions, Healthcare Institutes, Pharmaceutical, Biotech, CROs supply chain, Logistics practitioners making the congress a perfect platform to share experience, foster collaborations through the research talks & presentations to put forward many thought provoking strategies. It's a perfect stage to brainstorm, discover new ideas, search for new skills and a platform to show your capabilities and discoveries to the world. BABE 2016 will be one of the outstanding Bioavailability and Bioequivalence Conferences.

3D Tissue Models 2016

August 29-31, 2016

Hotel Karlan, San Diego, CA, United States

3D Tissue Models 2016 is designed to tackle critical questions about the true utility and limitations of 3D tissue models in pharmaceutical development. Hosting top decision makers from industry and academia, this unique summit will provide you with a collaborative platform to share and tackle your key drug development, biological and commercial challenges. The case-study driven agenda and data centric approach will reveal the practical applications of these technologies, going beyond the science of tissue engineering. Discover how leading pharmaceutical companies deploy organ-on-a-chip, organoid and other stem cell derived tissue technologies in drug discovery, toxicology, systems pharmacology and DMPK applications - to expedite discovery and translation to clinical research.

Post-approval changes for medicinal products in the EU - By Compliance Global Inc.

August 30-30, 2016

Online Training, New Hyde Park, NY, United States

Overview: This webinar will deal with the many different post-approval changes and describe which medicinal products regulations has to be followed. It will address the different types of variations (Type IAIN Variations, Type IA Variations, Type IB Variations, Type II Variations), but also extension applications, other types of post-approval changes, grouping of variations and work-sharing Type IA changes have little or no impact on the quality, safety or efficacy of the product, for example administrative modifications such as: the manufacturer’s name a minor change to a control method deleting details of where the product is packaged Type IAIN is a sub-type of Type IA where regulatory authorities require ‘immediate notification’, within 2 weeks of the change being implemented. If the change is more significant than an IA change but is not a Type II change or an extension, it is considered a Type IB change. Regulatory Authorities need to approve major variations (Type II variations) before they are made. Why Should You Attend: The legislation on the new scheme came fully into effect in 2013, but many companies report that they still need time to adapt to the changes. The EU system for dealing with applications for post-authorisation approvals is very complex and still in an implementation phase. On the other hand, the importance of post-approval changes is increasing due to the increasing number of changes. The number of variations per marketing authorisation has gone up considerably. Particular difficulties are seen with “grouping” of variations and “work-sharing”. A Company can apply multiple changes to a single product using the ‘grouping’ format, as long as the changes are directly related. For example, a Company can make a change to the manufacturing site of the finished product, change in batch size and the manufacturing process to one product. The type of procedure (Type IA, IB, II) depends on the extent of the change. In the work-sharing procedure one authority will assess the changes on behalf of all the other authorities involved. A Company can use the work-sharing format if the same Type IB or Type II change or group of changes to multiple MAs is submitted. Knowing and applying the rules will ensure that you can file the variations successfully and avoid rejections. Areas Covered in this Webinar: The webinar will start to explain that changes are classified as major (type II) or minor. Minor changes are either Type IA or IB. The Company can apply for: a single change to one marketing authorisation (MA) multiple changes to one or more products and/or MAs Type IB changes must be submitted to the Authorities and the company must wait 30 days before the changes can be implemented. Major variations (Type II) are more complex and may have a significant impact on the quality, safety and/or efficacy of the product. One example of a major change is adding a new therapeutic indication to a product or updating the current indication (the medical needs the product is used for). Although extensions are still considered a type of variation, their impact on a product is so significant that the Company will need to follow the application process to apply for a new MA. Extensions can be: changes to the active substance(s), including the salt/ester, isomer or biological active substance changes to strength, pharmaceutical form or route of administration If the variation (e.g. change of manufacturer) affects details of the labels, leaflets and or packaging of the product, the Company will need to include the updated versions with the submission to be assessed. Proposals for work-sharing applications should be sent to: the European Medicines Agency (EMA) if any of the MAs the Company wants to change were granted under the centralised procedure the Coordination Group for Mutual Recognition and Decentralised Procedures (CMDh) if the MAs were granted under the mutual recognition and/or decentralised procedures and the reference member states were different *the reference member state if the authorisations were granted under the mutual recognition and/or decentralised procedure and the reference member state is the same for each MA the competent authorities for the relevant countries if the MAs were granted under purely national procedures. Learning Objectives: Understanding how the system for post-approval changes for medicinal products in the EU works Being able to apply the rules for grouping and work-sharing Who Will Benefit: Regulatory Affairs Personnel Pharmaceutical Staff Biotech Personnel Senior management CRAs and CRCs QA / Compliance personnel QA / QC Auditors and Staff Consultants Speaker Profile: Adriaan Fruijtier has graduated as a pharmacist at the University of Utrecht, The Netherlands. He is currently Director Regulatory Affairs at CATS Consultants. Until March 2004, he has been Head of the Oncology Group within Global Regulatory Affairs at Bayer AG, Wuppertal, Germany, and Bayer Corporation, West Haven, CT, USA. Between 2001 and 2003, he was Director of Regulatory Affairs at Micromet AG, a biotech company in Munich, Germany. Prior to joining Micromet he has worked for four years as a Project Manager for Oncology Projects at the European Medicines Agency in London, United Kingdom. He joined the European Medicines Agency from Novartis AG, Basel, Switzerland, where he was Regulatory Affairs Project Manager in the Oncology group in 1996 and 1997. Before 1996, he was Head of Drug Regulatory Affairs for six years at Ciba-Geigy in the Netherlands, and has worked as Manager Regulatory Affairs at Glaxo, also in the Netherlands. For more detail please click on this below link: Email: Toll Free: +1-844-746-4244 Tel: +1-516-900-5515 Fax: +1-516-900-5510

Medical Device Software - do you understand how software is regulated?- By AtoZ Compliance

August 30-30, 2016

Online Training, New Hyde Park, NY, United States

Key Take Away: Learn the use of the FDA compliance, GAMP guidelines, 21 CFR Part 11 compliance, and other applicable industry software validation models, coupled with the ISO 14971 risk management / ICH Q9 quality risk management models, and their real-world implementation as requirements in medical device software. Overview: The medical device software / firmware is a high risk component of mission-critical medical devices. Its use is increasing. As such it comes under increased scrutiny by the U.S. FDA. Hence medical device software training is gaining in relevance. This webinar will primarily address the requirements in its regulation by the U.S. FDA. It will also consider key issues in the EU for CE-marked products. Key requirements under 510(k)s, IDEs and PMAs, will be evaluated, together with applicable guidance documents. Use of the FDA compliance training, GAMP, 21 CFR Part 11 compliance, and other applicable industry software validation models, coupled with the ISO 14971 risk management / ICH Q9 quality risk management models, and their real-world implementation as requirements in compliance will also be considered. A field-tested SW V&V documentation “model” to meet these requirements will be also be discussed. Why Should You Attend: Software /firmware have become pervasive in medical devices themselves, and as “devices”. Serious injuries / death caused by critical high-risk devices such as pumps can often be traced to software / firmware malfunctions. Software is being developed for medical imaging, and even thought control of computers for individuals having disabilities restricting hand or eye movement / coordination. The U.S. FDA rightly recognizes that virtually all software quality problems occur in the design, testing and validation phases, since replication of software is relatively defect-free. Consequently its submission processes reflect greater concern for the proper documentation and review of such software. Regulatory / submission auditors are more comfortable with delving into software issues. Field problems show the dangers of neglecting thorough, and risk based, software verification and validation activities. Effective and real world software documentation to prove compliance to requirements is mandatory. This webinar will present material that is readily adaptable to the controlling, running and monitoring of medical product processes, whether they be in the pharmaceutical, medical device, biologics or dietary supplements industries. Areas Covered In This Webinar: Medical software / firmware is coming under increased scrutiny by the U.S. FDA. This webinar will address the applicable 510(K), IDE, PMA requirements, and recommended guidance documents that drive the U.S. FDA’s expectations for and evaluation of submission documentation and marketing justification for devices containing software / firmware. Additional review of GAMP guidelines, 21 CFR Part 11, "Electronic Records" / "Electronic Signatures", and other applicable industry software documentation models, coupled with the ISO 14971 Product Risk Management models, to structure, run, and document acceptable software development, V&V and submission considerations. The FDA and other regulatory agencies have stated that software validation can only be accomplished effectively if “risk-based”. How can this be done in the "real world". This webinar will focus on field-tested (FDA and EU) approaches that work. The OEM manufacturer is responsible to identify these requirements and implement them into an effective software development, V&V, documentation and submission process, to include “life cycle” considerations, to include the holding of their suppliers to such requirements, or develop complementary systems to supplement. Learning Objectives: FDA Documentation and Regulatory Expectations Proven Development, V&V, submission documentation recommendations “Must Have” Documentation ISO / GAMP / Other Considerations Who Will Benefit: QA/RA Professionals R&D Professionals Engineering Professionals Production Personnel Operations Personnel Consultants Speakers Profile: John E. Lincoln John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 33 years' experience in U.S. FDA regulated industries, 19 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). For more detail please click on this below link: Email: Toll Free: +1- 844-414-1400 Tel: +1-516-900-5509 Fax: +1-516-300-1584

Corporate Responsibility and Compliance Issues for Behavioral Health Care Providers - By Compliance Global Inc.

August 31-31, 2016

Online Training, New Hyde Park, NY, United States

Overview: To achieve accreditation many behavioral health services are required to have essential classes to comply with accreditation body standards. This webinar will cover the essential elements necessary to obtain certification for your staff in corporate responsibility. The speaker will discuss the importance of the 3C’s of corporate responsibility - Communication, Clarity and Compliance. Why Should You Attend: Employee Training in Ethics and Corporate Responsibility is important when examining your organizations ability to comply with accreditation and local state managed care organization standards/laws. Has your staff been trained to recognized ethical issues in your organization? What rules has your organization established concerning health care law and ethics? What checks and balances regarding documentation errors are in place to prevent billing errors? These issues affect an agency’s ability to perform ethically and compliance ready. Areas Covered in this Webinar: Ethical considerations in monitoring and audits Advocating for persons served Delegation of authority Corporate compliance program with internal rules and state/federal authorities affecting responsible compliance Learning Objectives: Corporate governance and oversight requirements to remain audit ready Quality improvement and assurance to insure state/federal regulatory oversight Practical lessons in governance and staff communication to achieve sound corporate practices and compliance objectives Who Will Benefit: Behavioral Health Care Staff Compliance Staff QA/QI Administrators QA/QI Directors Administrators/Corporate Officers Behavioral health service managers and directors Behavioral health physicians Patient care staff, including psychologists, therapists, counselors and nursing staff Non-clinical administrative staff Medical records Coding Billing Speaker Profile: Dana G. Jones is an attorney with extensive experience in health care policy and litigation. Her emphasis is in behavioral health law management systems, Medicaid/Medicare litigation, and strategic planning. She is a popular speaker and trainer for various state departments and non-profit groups in health care compliance. Atty. Jones has law practices in North Carolina and Illinois. For more detail please click on this below link: Email: Toll Free: +1-844-746-4244 Tel: +1-516-900-5515 Fax: +1-516-900-5510

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September 2016

Analytical Method Validation Under Good Laboratory Practices (GLPs) - By Compliance Global Inc.

September 1-1, 2016

Online Training, New Hyde Park, NY, United States

Learn practical tips on how to validate an analytical method under the GLP requirements, including components of a validation and the importance of communication between the development and the validation labs and accuracy of transfer documents (SOPs).

Quality Control for Analytical Materials used in Microbiology Laboratories - By Compliance Global Inc.

September 6-6, 2016

Online Training, New Hyde Park, NY, United States

Overview: Many laboratories are unsure about which QC practices are needed and what criteria to use to assess the acceptability of the performance of analytical materials, to meet not only their requirements, but also to meet the requirements of ISO/IEC 17025. Why Should You Attend: During this webinar, we will discuss a practical QC approach for in-house prepared and/or commercially purchased media, test kits and reagents specifically applicable to microbiology laboratories. Areas Covered in this Webinar: Control Points (CP) Critical Control Points (CCP) Quality Control from purchase to disposal Performance Criteria Sterility Productivity Selectivity Learning Objectives: To understand intrinsic and extrinsic factors which can affect the performance of culture media, test kits, reagents and other analytical materials To identify Control Points (CP) and Critical Control Points (CCP) in media quality assessment Who Will Benefit: Microbiological Bench Analysts QA Managers Microbiology Laboratory Managers/Supervisors QC Practitioners Speaker Profile: Michael has been an Environmental Microbiologist for more than 42 years. He is a Past President of the Ontario Food Protection Association (OFPA), the International Association for Food Protection (IAFP) and AOAC International. He serves as Chair for the AOAC Expert Review Committee for Microbiology, as a scientific reviewer in Microbiology for the AOAC OMA and the AOAC Research Institute, as a reviewer for Standard Method for the Examination of Water and Wastewater and as a chapter editor on QA for the Compendium of Methods in Microbiology. He is also a lead auditor/assessor in microbiology for the Canadian Association for Laboratory Accreditation (CALA) and is Vice-chair of the CALA Board of Directors. For more detail please click on this below link: Email: Toll Free: +1-844-746-4244 Tel: +1-516-900-5515 Fax: +1-516-900-5510

The Best Way to Develop or Improve a Master Validation Plan

September 6-6, 2016

Online Training, New Hyde Park, NY, United States

Overview: How to develop or improve upon a Master Validation Plan / Validation Master Plan or System that meets U.S. FDA CGMP, ICH Q-series, and ISO 13485 expectations and requirements. FDA Warning Letters and recent high-profile recalls indicate major cGMP regulations deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning. Starting with a Validation Master Plan, evaluating its elements against ISO 14971 process hazard analysis / risk management plan, allows development of meaningful product validations. The roles of different V&V protocols. How to employ equipment / process DQs, IQs, OQs, and PQs, or their equivalents per ASTM E2500, against a background of limited company resources (personnel, budget, time). A matrix simplifies “as-product”, “in-product”, process, and equipment, et al, software V&VT, assuring key FDA requirements are not overlooked. The QMS and 21 CFR Part 11 must also be considered. Why Should You Attend: Verification and validation requirements have always been part of the US FDA’s GMPs. However, with increasing technology, both industry and regulatory agencies expectations have increased. Recent high-profile field problems indicate that V&V activities are not planned or carried out as completely as expected, cannot be analyzed as to inventory impact, do not consider allowable “worst case” inputs, are not documented in a top tier Master Validation Plan, and may not be fully utilizing the power of current risk management tools, as identified in ISO 14971. The FDA / ICH Q-series provide valuable insights for all regulated industries, not just pharma. The billions of dollars spent by industry annually for V&V are not providing the product safety or efficacy seemingly promised. For most companies, the fixes are not rocket-science, but proper up-front V&V planning and execution, documented in a corporate MVP and implemented by other V&V documents. Areas Covered in this Webinar: The Master Validation Plan and its structure Product Validation – how it differs from process / equipment V&V Process / Equipment / Facility Validation -- including FDA's recent Guidance When and How to use DQ, IQ, OQ, PQ, or their equivalents How to use Product Risk Management Tools (per ISO 14971 and ICH Q9) The 11 key documents for software validation Incorporating 21 CFR Part 11 requirements Suggested “test case” formats Putting it all together Learning Objectives: Sort through all the differing theories, outright misstatements on Internet forums and understand a field-proven system. Understand the unstated regulatory requirements for a MVP/ VMP. The nature and structure of the VMP document(s). How the VMP feeds the individual Validation Plan. Know the similarities and differences in: Product V&V Process V&V Equipment V&V Software / Firmware V&V – In-product, As-product, Equipment, and ERP / QMS Be able to define, structure and resource a corporate and satellite / plant V&V system(s). Who Will Benefit: Senior management in Drugs, Devices, Biologics, Dietary Supplements QA/RA Professionals R&D Professionals Engineering Professionals Operations Professionals Manufacturing Professionals Document Control Professionals Speaker Profile: John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 33 years' experience in U.S. FDA regulated industries, 19 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). For more detail please click on this below link: Email: Toll Free: +1-844-746-4244 Tel: +1-516-900-5515 Fax: +1-516-900-5510. 

FDA Chapter 21 CFR Subpart C Section 820.30 – Design Control Requirements - By Compliance Global Inc.

September 7-7, 2016

Online Training, New Hyde Park, NY, United States

Overview: This webinar will discuss why certain steps are so important in the design process and that many steps are not just wasted time and paperwork. The process is a methodical approach that can be used with almost any product development process from concept to production based on medical device regulations. The speaker has a proven track record of successful products and many of them have been on the market longer than the 5 or 10 year expected product life cycle. The speaker has 20 granted patents and over 83% percent of them have been commercialized and using this process. Why Should You Attend: The medical device design control process can be long and costly, but not if you follow some proven guidelines and steps. Sometimes projects are continuously pushed forward without doing proper reviews to see if the project warrants going to the next step. The sooner this process is done the better as it saves time and money. Good products also need to be completed faster and with less capital to beat the competition to market and beat them with a good quality product that needs little to no revisions and one that receives very few to no complaints from the customer. This webinar will teach you the secrets of turning your medical device ideas into profit making products, which are the same steps that can also enable you to see why the project should be cancelled. Areas Covered in this Webinar: • How to start a new product development process • Patent search for new medical devices • Putting together a comprehensive systems requirement document • 1-10-100 Rule • Market research and customer needs • Design in quality & manufacturability • Prototype & testing • Production Tooling • Qualification, Validation, & Verification • Trace Matrix Learning Objectives: • FDA Chapter 21 CFR Subpart C Section 820.30 – Design Control Requirements • Technical File & Regulatory Documentation for Medical Device Manufacturers • The complete Medical Device Product Development Process Who Will Benefit: • Medical Device Design Engineers • Product Managers • Directors of Product Development • VPs of Product Development • Inventors • Project Leaders • Technical Team Leaders Speaker Profile: Karl R. Leinsingis currently the President of ATech Designs, Inc., a Medical Device product development and consulting firm in North Carolina. Karl has Medical Device and automation experience since 1986. His areas of expertise include full life cycle product development of medical devices from conception through development including manufacturing, bench testing, verification, validation, packaging, labeling, clinical trials, regulatory approval, marketing, and sales training. For more detail please click on this below link: Email: Toll Free: +1-844-746-4244 Tel: +1-516-900-5515 Fax: +1-516-900-5510

To Quality and Beyond: Recent Developments in Medicare Reimbursement - By AtoZ Compliance

September 7-7, 2016

Online Training, New Hyde Park, NY, United States

Key Take Away: This webinar discusses changes in the physician payment landscape arising from several of physician quality reporting system, with particular focus on the Medicare changes resulting from the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). And, addresses the shift in Medicare away from traditional fee for service payment models, towards more value- and quality-based payment by examining the reporting requirements and new compliance difficulties that physicians and physician practices will need to understand. Overview: This webinar discusses the history of Medicare's physician quality and value initiatives and recent changes in Medicare reimbursement and Medicare insurance. Why Should You Attend: Medicare currently operates several interconnected quality reporting systems. These are: (1) the Physician Quality Reporting System (PQRS); (2) the “Meaningful Use” program; and (3) the Value-based Payment Modifier. These programs will be incorporated into Medicare’s forthcoming Merit-based Incentive Payment System (MIPS). Data reported today will determine whether physicians receive upward or downward payment adjustments to their compensation in the future. Currently, physicians face a range of upward and downward payment adjustments to the entire universe of their Medicare Physician Fee Schedule payments; under MIPS, this amount will eventually be +/- 9%. Improper reporting may require repayment of money to Medicare, and may result in exposure under the Federal False Claims Act, which recently had its penalties nearly doubled. Given the complexity of these systems, and the potential risk associated with improper reporting, physicians must develop effective compliance strategies to minimize their risks. Areas Covered In This Webinar: In recent years Medicare has increased the number of programs which track physician-reported data. These programs, which include PQRS, EHR Meaningful Use, and the Value-based Payment Modifier, each bind Medicare physician fee schedule (MPFS) patients to the reporting of data. The process of reporting such data, however, is complex. Physicians must choose which reporting mechanism is most appropriate for them, and different mechanisms require the reporting of different data. Physicians who fail to report properly may face reductions in MPFS payments. In addition, there is often a delay of up to two years between when the data is reported and when payment adjustments are applied. Moreover, improper reporting that avoids a payment reduction could result in an overpayment, which could become a false claim under the federal False Claims Act. The Merit-based Incentive Payment System (MIPS) will consolidate much of the current reporting, but will ultimately increase the range of upward or downward payment adjustments for physicians. Learning Objectives: • Examine the three physician reporting programs currently in use by Medicare: PQRS, Meaningful Use, and the Value-based Payment Modifier • Get a brief background for each program, and discuss common problems and areas of overlap between them • Know MIPS, and how the current systems relate to it • Understand the False Claims Act liability inherent in both the current systems and in MIPS, and how improper reporting under these systems can potentially result in overpayments • Learn proactive steps that physician practices can take to help ensure compliance with these systems to avoid such liability Who Will Benefit: • Physicians • Physician Practice Managers • Compliance Officers for Health Care Providers • Medical Staff • Allied Health Professionals Speakers Profile: Daniel Shay DANIEL F. SHAY is an attorney with Alice G. Gosfield and Associates, P.C. His practice is restricted to health law and health care regulation focusing primarily on physician representation, fraud and abuse compliance, Medicare Part B reimbursement, and HIPAA compliance in the physician context. He also has a keen interest in intellectual property issues, including copyright, trademark, data control, and confidentiality. For more detail please click on this below link: Email: Toll Free: +1- 844-414-1400 Tel: +1-516-900-5509 Fax: +1-516-300-1584

Leading on Biosimilars: The 2016 GPhA Biosimilars Council Conference

September 7-8, 2016

Bethesda North Marriott Hotel and Conference Center, North Bethesda, MD, United States

GPhA and its Biosimilars Council are pleased to announce our 2016 two-day conference - Leading on Biosimilars. Hear presentations from key industry leaders, agency officials, and academic experts on areas of focus that will include education, access, regulatory environment, reimbursement and legal affairs.

Join us at our first conference hosted by GPhA Biosimilars Council. Hear presentations from our keynote speaker, Dr. Janet Woodcock,along with key industry leaders, and academic experts on areas of focus that will include education, access, the nascent regulatory environment, reimbursement and legal affairs. Don’t miss out on our “CEO’s Unplugged” session, where corporate leaders participate in a relaxed and candid discussion about top business news and emerging industry trends. Space is Limited. Register Today!

Phase I GMPs - By Compliance Global Inc.

September 8-8, 2016

Online Training, New Hyde Park, NY, United States

Overview: Early clinical trial phases are conducted to establish initial safety of a drug. The drug trial studies are generally in small number of healthy subjects and use lower doses of the drug product. Therefore, only small amounts of investigational material are required. In order to not undertake substantial costs and to reduce regulatory burden during these early stages, the FDA has allowed early stage investigational products to be manufactured under less stringent GMP guidelines. Why Should You Attend: This webinar will review the current regulations, guidance documents for early stage manufacturing and GMPs in detail. Regulatory strategies and logistical considerations for early development stage product, including vendor selection and management, stability, labeling, and documentation requirements will also be reviewed and explored. Areas Covered in this Webinar: • FDA regulations and Guidance Documents for Phase I clinical trials • Key elements and Best practices of GMP for Phase I clinical trials • IND content and format for CMC information • Vendor selection and management for outsourcing early manufacturing • Raw material selections and considerations Learning Objectives: • Understand the differences permitted for phase I GMP compliance regulations • Ensure that all of the right systems and procedures are in place Who Will Benefit: • Directors • Managers/Supervisors • Regulatory Affairs • Manufacturing • Quality Assurance and Clinical Operations Speaker Profile: Peggy J. Berry, MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics. Prior to founding Synergy Consulting in 2015, she was Vice President of Regulatory Affairs at Insmed (2/2015-5/2015) where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. Prior to Insmed, she was Vice President of Regulatory Affairs and Quality at Amarin (3/2009-2/2014). For more detail please click on this below link: Email: Toll Free: +1-844-746-4244 Tel: +1-516-900-5515 Fax: +1-516-900-5510

Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions

September 8-9, 2016

Venue to be announced shortly, Barcelona, Non-U.S., Spain

Raw Material Requirements in a cGMP Environment | Health Canada, USP, EP

World Anti-Microbial Resistance Congress USA 2016

September 8-9, 2016

Washington Court Hotel, Washington, D.C., DC, United States

The World AntiMicrobial Resistance Congress gathers key stakeholders from government, funding agencies, pharma, academia, hospitals, and payers to discuss this urgent need for new antibiotics. President Obama has outlined his 5-year action plan to fight AMR and is seeking to double the AMR funding to USD 1.2B, but the bigger challenge is how to deliver these actions. This 2-day conference presents solutions through key notes, case study presentations, expert opinion, roundtable discussions and invites key influencers such as BARDA, NIH, FDA, grant agencies, pharma, hospitals, and academia, in the AMR discussion. We understand the importance of focused learning and enhanced networking so we have put together a conference that brings together innovative formats with 5+ hours of assisted networking during 40-minute coffee breaks and 1 ½ hour lunch breaks. We end Day One with a Cocktail Hour so that you can network with your peers in a more relaxed setting! If you are developing an antibiotic or provide solutions to develop antibiotics, prevent spread of AMR, monitor it in real time or have alternative ways to fund antibiotic R and D, don’t miss out. Be sure to join us at the World AMR Congress this September.

Process WATER Technologies

September 11-14, 2016

Texas A&M University, College Station, TX, United States

The Separation Sciences Program in the Food Protein Research and Development Center at Texas A&M University presents a “hands-on” WATER Short Course covering pretreatment equipment, processing, systems, field testing, case studies, and post-treatment technologies to food, dairy, & beverage industries. Now is the time to see how it works from the leading water and equipment professionals.

2016 PDA/FDA Joint Regulatory Conference

September 12-13, 2016

Renaissance, DC Hotel, Washington, DC, United States

For the past 25 years, the PDA/FDA Joint Regulatory Conference has provided an exclusive forum in which to hear directly from FDA speakers regarding current Agency efforts that could potentially impact the development of global regulatory strategies. Take advantage of a level of direct exchange with the FDA not found at any other conference.

Best Practices for an Effective Cleaning Validation Program

September 12-13, 2016

The Desmond Hotel and Conference Center, Malvern, PA, United States

This course provides practical guidance on cleaning validation regulatory compliance, in conjunction with process validation principles to facilitate reasonable and informed decision making and activity planning. Regulatory requirements and the latest industry practices will be included in the discussion to identify questionable practices that may be misdirected as well as the better practices that support and align with current process validation principles. The program will describe a risk-based approach for establishing an effective cleaning validation program, including the development of policies, master plans and the appropriate content for each study to be performed incorporating critical quality attributes and critical process parameters and process control. In addition, validation maintenance and life cycle aspects will be reviewed. Cleaning validation examples will be included from different sterile and non-sterile product types, and different types of dosage forms including oral, topical, and injections. Concepts will apply to any FDA regulated manufacturing including drugs, supplements, personal care, medical devices. Additional benefits of this class include interacting and learning from peers. Participants will have the opportunity to discuss their challenges and problems.

Trial Master Files

September 12-14, 2016

IQPC Ltd, London, Non-U.S., United Kingdom

Are you looking to: Represent a complete TMF and ensure inspector readiness? - The Danish Medicines Agency present a case study to ensure you are inspection ready Effectively manage internal and external correspondence? - UCB share their expertise Successfully convert to a cost-effective eTMF system? - Mitsubishi Tanabe share their expertise Ensure positive CRO oversight that ensures TMF completeness, quality and timely delivery? - Covance and Biomarin share their two differnt perspectives Ensure efficiency with a perfected interoperabilitystrategy? - Phlexglobal offer their insight In this 100% case study and discussion based event, we are joined by industry experts from across pharma and regulatory bodies, who will help you solve all of your TMF challenges!

European CNS Summit 2016

September 12-14, 2016

The DoubleTree by Hilton Hotel London – Docklands Riverside, 265 Rotherhithe Street, London, Non-U.S., United Kingdom

The European CNS Summit 2016 will build on the success of the 4th annual World CNS Summit, to drive translational research in the field of neurodegeneration and accelerate the development of novel therapeutics. Bringing together scientific thought leaders from academia, pharma and biotech actively working in the neurodegenerative space worldwide, this summit will reveal the latest breakthroughs as the paradigm for RandD in the field is rewritten. Place yourself at the pinnacle of this rapidly evolving industry by examining innovative therapeutic approaches, in conjunction with advances in biomarker development, neuroimaging and patient stratification. The collaborative nature of the meeting will enable you to share and tackle critical pre-clinical and clinical barriers with the aim of streamlining translational research across the field. Join our expert speaker faculty to challenge traditional thinking around the development of effective treatments against neurodegeneration.

2016 Pharma CI Conference and Exhibition

September 13-14, 2016

Hilton Parsippany Hotel, Parsippany, NJ, United States

The Best and Largest Assembly of Pharmaceutical Competitive Intelligence Executives! This is the industry's gold standard for senior level pharma, biotech, and medical device professionals who seek the latest in competitive and business intelligence. The setting is casual and intimate, yet this event also happens to have the highest ratio of industry practitioners (pharma biotech, medical device and diagnostics) of any pharma intelligence conference! Join us at this premier gathering and network with other key decision makers as you learn about the most pressing and relevant issues facing the competitive intelligence community today. This is the only event featuring a world-class lineup of speakers and panelists offering their unique insights and expertise on the topics you care about most!

2016 PDA Data Integrity Workshop

September 14-15, 2016

Renaissance Washington, DC Hotel, Washington, DC, United States

The 2016 PDA Data Integrity Workshop, offered several times in global locations, will explore the multiple facets of data integrity, such as quality culture, human behavior, training needs and technology requirements. Through case studies, presentations and breakout sessions, this interactive, must-attend event will help you learn implementable, best practices for preventing, detecting, mitigating and remediating data integrity issues.

Essentials Of USP Microbiology - Reading Between the Lines of the USP General and Information Microbiology

September 15-16, 2016

Venue to be announced shortly, Philadelphia, PA, United States

Learn essentials of USP microbiology - reading between the lines of the USP general and information microbiology chapters. Explore Form FDA 483s and Warning Letters for microbiological applications.

ISPE 2016 Annual Meeting & Expo

September 18-21, 2016

Atlanta Marrriott Marquis, Atlanta , GA, United States

The ISPE Annual Meeting offers a wide range of industry- and career-advancing opportunities. Network and problem-solve with top pharmaceutical and biopharmaceutical professionals, learn about important industry topics, meet with suppliers, and share best practices with colleagues. This premier event is designed for everyone in the industry from young professionals to senior executives with: the latest trends and a broad spectrum of technical. Register today!

Investigator Site Files Summit

September 19-20, 2016

Wyndham Boston Beacon Hill, 5 Blossom St., Boston, MA, United States

Over the course of two days, industry leaders at the Investigator Site Files Summit will take part in case studies, a panel and engaging sessions developed to ensure conference attendees walk away with a better understanding of how proper document management of the ISF can increase a clinical trial’s quality while monitoring the progress of a trial. In addition to our main program, our pre-conference workshop teaches attendees how to build an ISF management plan that can be used by the sponsor as a template for all sites in a study or by the investigative site for all studies they are conducting. Join us to enrich the quality of your ISF and protect your organization from the risks incomplete, outdated or inaccurate files can cause.

Pharmaceutical and Biopharmaceutical Quality Control Laboratories - A Regulatory Compliance Primer

September 19-20, 2016

The Desmond Hotel and Conference Center, Malvern, PA, United States

This course is intended to give participants a thorough overview and practical understanding of Current Good Manufacturing Practices for laboratory compliance including: •General requirements for design and construction of analytical laboratories •Calibration and Qualification of instrumentation and equipment •Documentation, records-keeping and change control •Management of reagents, test solutions and reference standards •Personnel development and training

5th Annual Bioplasma World Asia 2016

September 19-21, 2016

Hong Kong, Hong Kong, Non-U.S., China

Bioplasma World 2016 has achieved a record breaking success by increasing participation by 30% from 2014, and the 5th Annual Bioplasma World Asia has firmly established itself as the most definitive and most important annual meeting place for the plasma products industry year after year!

Advanced Pharma Analytics USA 2016

September 20-22, 2016

Hyatt Morristown at Headquarters Plaza, Morristown, NJ, United States

As the pharmaceutical industry strives to extract meaningful insight, value and outcomes from their data analytics, pharma and biotech are experiencing a significant movement towards real-world evidence to power the advanced decision-making to optimize patient-centric approaches. This evolution has led to a fresh focus for the 4th Annual Advanced Pharma Analytics Summit (formerly know as Big Data in Pharma). Join the industry to learn about the successful application of advanced data analytics tools, including big data and predictive analytics, to progress products in the late stages of their life cycle. This year’s summit will also highlight the significant opportunities present within real-world evidence to compliment clinical trial data and to drive forward regulatory approval and post-approval evidence. The 4th APA Summit 2016 will showcase the latest case studies from the likes of Genentech, Pfizer, Novartis and the FDA that demonstrate value and tangible ROI derived from effective data sourcing, standardization, integration, infrastructure, real-world evidence and advanced analytics. Discover the right technology, tools and customized analytics capabilities you need to make improved data-driven decisions to optimize health economics, market access, pricing and reimbursement strategies. Join the Advanced Pharma Analytics community to fully realize and extract the right value and insight you need from your data and real-world evidence.

Medicaid Drug Rebate Program Summit

September 20-22, 2016

The Palmer House Hilton, Chicago, IL, United States

Now in its 21st year, IIR's MDRP Summit has continued to be THE authoritative MDRP Event for Everything Government Pricing, Rebates and Regulation. MDRP provides unparalleled access to the government.

The A to Z's of Microbial Control, Monitoring and Validation of Water Systems for Pharmaceuticals, Biologics, Medical Devices, Cosmetics, and Personal Care Products

September 22-23, 2016

Courtyard Boston Cambridge 777 Memorial Drive, Cambridge, MA, 02139, USA, Cambridge, MA, United States

Course Description: All facilities manufacturing pharmaceuticals, biologics, medical devices, cosmetics, and personal care products are likely to have high purity water systems. In spite of this purity, microorganisms can flourish within these systems and lead to undesirable contamination of facility processes and their products. Of all the individuals at the facility, it is site’s microbiologists who should understand the microorganisms in water systems and how best to monitor and control them. Sadly, this is often not the case due to the lack of familiarity with biofilm and its impact on water system sampling, testing, sanitization, and routine maintenance. This lack of understanding of microbial control often leads to poor system designs, poor system sampling, poor system maintenance and poor sanitization practices, and as a result, ongoing microbial problems with the water. This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training, though a plus, is not a requirement, since this training is for everyone involved with water systems, from the lab to utility room operations. The instructor will provide the necessary background needed to understand this very important subject matter. This understanding is essential for the proper design, validation, operation, monitoring, and maintenance of a high purity water system. Without this understanding, water system control and monitoring consists of a set of rules that often don’t work or result in erroneous monitoring data and can cause everything from very costly and unnecessary system downtime to patient injury and product recalls.

New Perspectives In Hepatitis C Virus Infection - The Roadmap For Cure

September 23-24, 2016

Marriott Rive Gauche, Paris, Non-U.S., France

This event is being co-organized with the American Association for the Study of Liver Diseases (AASLD) and is useful for hepatologists, virologists, translational and clinical researchers, health professionals and young trainees. Topics to be covered include; Epidemiology, Pathogenesis and Virology, HCV Assessment and Treatment, Special Patient Populations, Clinical and Translational Research. The recent and rapid advances in the treatment of hepatitis C have completely changed the scenario of this disease in the last months. It is not always easy to be updated in the field, due to the huge amount of data coming from a large number of published studies. Antiviral drugs that are still not approved in some countries are already classified as "old" and current treatment regimens may be replaced by new ones by the time the meeting takes place. The aim of the EASL-AASLD Special Conference is to summarize the information available, as well as to provide a critical review and analysis of the best available data (some unpublished data will be relevant). With this goal in mind, this meeting will give hepatologists, as well as other specialists interested in hepatitis C, the opportunity to catch up with the new advances in the field and be able to apply them in clinical practice. To reach this aim, an international panel of key experts and participants will actively interact to resolve pending issues and to highlight areas needing further analysis and investigation. Sponsorship and exhibition opportunities are available for those interested in making a lasting impression within the global liver community.

2016 Annual Meeting of the American College of Clinical Pharmacology

September 24-27, 2016

Bethesda N Marriott Hotel & Conf Ctr, N Bethesda, MD, United States

Please join us September 25th - 27th at the Bethesda N Marriott Hotel & Conference Ctr in Bethesda, MD for Clinical Pharmacology: Discovery & Application in the Era of Precision Medicine. In accordance with ACCP's commitment to excellence in science and education, the meeting includes a diverse and exceptional educational program that meets the needs of a broad spectrum of healthcare professionals and scientists with an interest in clinical pharmacology applications from research and drug development to patient care. Speakers from academia, industry, regulatory and clinical entities will present programs organized into topic tracks that allow attendees to uniquely tailor content selection to their individual interests. This is relevant for those in academia, industry, regulatory and clinical care involved in research, drug development and clinical care. For Exhibit & Sponsor opportunities, please contact 571-291-3493.

3rd Bioequivalence Summit

September 26-27, 2016

Hilton Boston Logan Airport, Boston, MA, United States

Every new formulation and generic drug needs to demonstrate bioequivalence to secure market approval. But each of these required tests can be complicated by innovations in drug delivery or dosing features, yielding unpredictable challenges if companies modify delivery techniques to try to improve bioavailability. The 3rd Bioequivalence Summit is your must-attend event for achieving true interchangeability of both small molecule generics and biosimilars across multiple delivery platforms. No other conference goes into as much depth of scientific detail in order to help broaden the robustness and market uptake of your generic and biosimilar portfolio.

Additive Manufacturing for MedTech, Bioprinting, Medicine and Dental

September 26-28, 2016

Philadelphia, PA, United States

The 4th Annual Additive Manufacturing for MedTech, BioPrinting, Medicine and Dental Summit will take a comprehensive approach to understand the latest printing techniques, groundbreaking research and innovative materials for an improved additive manufacturing strategies, implementation and processes. Attendees will have the opportunity to participate in cutting-edge conversations on emerging technologies, applications, and solutions required to stay up-to-date in the marketplace.

The Career Fair 2016

September 27-27, 2016

Raritan Center - The NJ Convention and Exposition Center, Edison, NJ, United States

On September 27, 2016 will be hosting our annual Career Fair. The Career Fair 2016 will take place at Raritan Center - New Jersey Convention & Exposition Center in Edison, NJ. There will be no recruiting agencies participating in this event, making it one of the few times candidates will meet exclusively with direct employers from the life science industries. This means direct access with the exact contacts that will do the interviewing and no middle men! Exhibiting Companies: Novo Nordisk, Inc. ***Platinum Sponsor*** Merck *Silver Sponsor* Covance *Silver Sponsor* AstraZeneca *Silver Sponsor* MedImmune Acorda Therapeutics Medidata Solutions AuroLife Pharma, Inc. NYU Langone Medical Center Daiichi Sankyo Allergan Catalent Pharma Solutions Teva Pharmaceuticals Intergrated Project Management Company SUN Pharma Sollers, Inc. More to come... Required qualifications to attend: Attendance is free. Candidates must possess a 4 year life science related degree and 2 years professional experience working for a Life Science related company. You may pre-register for the event at An invitation to attend will be sent if the minimum qualifications are met. A general overview of job categories companies will be hiring for: -Bioinformatics -Clinical Research -Laboratory -Manufacturing -Medical Device -Regulatory Affairs -Research & Development -Pharmaceutical/Medical Device Sales & Marketing -Pharmaceutical IT Applicable fields include but are not limited to: Bioinformatics, Biostatistics, Clinical Research- Drug safety, Laboratory- Animal/Veterinary, Laboratory - QA, Laboratory - QC, Laboratory - Validation, Manufacturing, Process Development, Medical Communications, Medical Device, Regulatory Affairs, All Biology, All Chemistry, Analytical Chemistry, Biochemistry, Biomedical Engineer, Bioprocess Development, Biotherapeutics, Cell Biology, cGMP, Chemical Engineer, Electrical engineer, Genetics, Immunology, Mechanical Engineer, Microbiology, Molecular Biology, Oncology, Pathology, Pharmacology, Synthetic Chemistry, Toxicology, Sales and Marketing, Business Development, Client Services, Medical Liaison, Product Management, Pharmacokinetics, Virology...

Sensors Midwest

September 27-28, 2016

Donald E. Stephens Convention Center, Rosemont, IL, United States

We’re back! Co-located with SMTA International, Sensors will be bringing the best technical innovation and thought leadership in the world of sensors back to the Midwest. Sensors Midwest will focus on hot and trending sensor technologies including Embedded Systems, Printed/Flexible/Wearable, IoT, MEMS, Robotics, Wireless, and much more!

The 2-day event will feature education, networking, and a packed Expo Floor with an anticipated 65+ exhibitors showcasing their latest sensing technology and products. The Education Program will feature different tracks that will explore cutting-edge trends & applications, case studies, and demos from the industry’s leaders and experts. With Education Theaters directly on the Expo Floor, networking opportunities & parties, and direct access to both SMTAI and Sensors Midwest events, attendees are guaranteed to explore new technologies and find solutions to their current sensing challenges.

Join us this September 27-28 in Rosemont, Illinois as we celebrate our return to the Midwest!

Visit to register today and for the latest information on the 2016 event. Register soon - Expo Passes are FREE for a limited time!

Good Manufacturing Practices (cGMP)

September 27-29, 2016

The Los Angeles Airport Hilton, Los Angeles, CA, United States

This course covers the foundations of the regulations that control the manufacture and distribution of pharmaceutical, biologic and medical devices sold in the United States. CGMPs are defined for all Food and Drug Administration (FDA) Regulated products in Title 21 CFR 210/211. Application of the regulations will be discussed and examples provided throughout the course. Attendees will gain an understanding of how knowledge of the regulations facilitates efficient and cost effective production and problem resolution. Each section of 21 CFR 211 (Current Good Manufacturing Practices [CGMP] for Finished Pharmaceuticals) will be covered interspersed with references from 21 CFR 600/610 (Biological Products: General) and 21 CFR 820 (Quality Systems Regulations). Although CGMP refers to 21 CFR 210/211 the other Parts (600 and 820) rely on Part 211 as well. In addition to the above, ICH, EU, and other comparisons will be made in order to provide a complete understanding of the regulations. The course provides a complete overview of the industry requirements as specified by the FDA.

PSA: The Pharmaceutical Strategy Conference

September 28-30, 2016

Marriott Marquis Times Square, New York, NY, United States

As blockbuster acquisitions, asset swaps, and divestitures continue into 2016, we examine the key scientific, development, commercial, and business model issues facing an industry tasked with proving the value of its therapies like never before. Hear from thought leaders across the spectrum of biotech, pharmaceutical, and payer perspectives as the drug industry embraces new strategies for long-term success.

In-Person Seminar On Pharmaceutical cGMP, Data Integrity and FDA Inspections – Current Challenges and Preparations

September 29-30, 2016

Compliance Trainings, Mumbai, Non-U.S., India

Description: What are the Current Good Manufacturing Practice regulations (cGMP) for Finished Pharmaceuticals (cGMP)? Why is it required to follow these regulations? This seminar will provide a review of cGMP regulations with explanations that will demonstrate the benefits of complying with these simple rules. You will learn how to prepare for and what is the appropriate conduct during FDA Inspections. Acquire the suitable skills necessary for responding to FDA’s questions. Descriptions of what records you have to provide and what records you should not provide to FDA. Learn how to write a procedure for preparing for FDA and other regulatory agency inspections. The importance of data integrity and control of electronic records, with particular regards for recent problems with Indian API manufacturers. A comprehensive review of having and following written laboratory investigation procedures. Providing and maintaining adequate audit trails for traceability to your original data. A short role playing exercise will be conducted, which will help you to learn appropriate behavior during regulatory inspections.

2 Day In person Seminar on Pharmaceutical cGMP, Data Integrity and FDA Inspections – Current Challenges and Preparations

September 29-30, 2016

TBD, Mumbai, Non-U.S., India

A must attend seminar for professionals in Pharmaceutical development and quality control companies, Manufacturers of drug substances (APIs), Finished Products, Contract laboratories and Clinical Research Organizations. This seminar will provide a review of cGMP regulations with explanations that will demonstrate the benefits of complying with these simple rules. You will learn how to prepare for and what is the appropriate conduct during FDA Inspections. Acquire the suitable skills necessary for responding to FDA’s questions. Descriptions of what records you have to provide and what records you should not provide to FDA. Learn how to write a procedure for preparing for FDA and other regulatory agency inspections.The importance of data integrity and control of electronic records, with particular regards for recent problems with Indian API manufacturers. A comprehensive review of having and following written laboratory investigation procedures. Providing and maintaining adequate audit trails for traceability to your original data. A short role playing exercise will be conducted, which will help you to learn appropriate behavior during regulatory inspections.

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October 2016

EuPAT8: Eighth pan-European Science Conference on QbD and PAT Sciences

October 2-4, 2016

Devere Hall, Cork, Non-U.S., Ireland {Republic}

The EuPAT8 will focus on PAT integration into pharmaceutical manufacturing, the biopharmaceutics risk assessment roadmap (BioRAM) for the integration of preclinical, clinical and pharmaceutical development including QbD for better products and QbD considerations for emerging therapies (biosimilars and nanomedicines). Technical, practical and regulatory challenges in each of these focus areas will be explored and debated in detail. The conference builds on the success of the EuPAT series established in 2006 and will be organised by EUFEPS and its QbD and PAT Sciences Network, cosponsored by the University College Cork (UCC), the Irish based Synthesis and Solid State Pharmaceutical Centre (SSPC) and Pharmaceutical Manufacturing Technology Centre (PMTC). It is organised back-to-back with a training day centred on “Considerations for implementing a PAT technology into a new or existing pharma process”, which will be organised, at the School of Pharmacy, UCC. The attendees of EuPAT8 are welcome to register for the pre-conference day and vice versa. Session Topics at EuPAT 8 are: PAT implementation in manufacturing I (small molecule) PAT implementation in manufacturing II (biologics) Biopharmaceutics risk assessment roadmap (BioRAM) Biosimilars and Nanomedicines For Preliminary Programme, see website.

3rd Annual Drug Discovery USA Congress 2016

October 3-4, 2016

Hilton San Diego Mission Valley, San Diego, CA, United States

Oxford Global Conferences are proud to present the 3rd Annual Drug Discovery USA Congress, taking place on 3-4 October 2016 in San Diego, USA. Our Congress brings together a host of senior level experts to discuss recent developments in the industry and debate the best strategies and solutions to improve drug discovery going forward. Over 150 delegates representing global pharmaceutical organisations, leading biotech companies and internationally renowned academic institutions 40 presentations and case studies focused on the key issues in drug discovery and medicinal chemistry 4 Interactive Streams: - Target Based Discovery - Screening & Assays: Enabling Technologies - Discovery Chemistry & Drug Design - Supporting Innovation: Translational Approaches & Informatics Tools 14 pre-scheduled one to one meetings, exhibition and informal networking opportunities. The drug discovery landscape is changing rapidly. With the cost of bringing a drug to market rising, researchers are seeking innovative ways to increase the efficiency of their R&D pipelines. On the first day of our Drug Discovery USA Congress our expert panel of speakers will address the current strategies for directed discovery, including the resurgence of phenotypic screening and comparing its utility with target based discovery. Our renowned speakers will explore novel peptide drug discovery, strategies for target selection and incorporating genomic technologies into discovery research. Day one also features an exciting stream covering the latest screening and assay technologies, such as novel stem cell assays, exciting new phenotypic screening strategies and how to use stem and primary cells for physiologically relevant disease models. The pharma industry is seeing an increased focus on strengthening data and knowledge management in R&D pipelines to make the most of discovery data. Researchers are seeking new techniques to manage complex early stage discovery portfolios and for library optimisation. On day two our Congress features an exciting stream dedicated to supporting innovation with informatics tools in which we will explore new data analysis and integration platforms, as well as ideas for efficient data exchange and pre-competitive collaboration. Day two will also host discussions about the latest research in the discovery chemistry field, with exciting case studies covering computational tools for gene editing and drug design as well as fragment based drug discovery case studies.

Asia-Pac Trial Master File Summit

October 3-4, 2016

The Westin Tokyo, Tokyo, Non-U.S., Japan

For the last six years, ExL's Trial Master File Series has explored the challenges and evolution of the TMF landscape in the United States and United Kingdom - but we know the obstacles you and your colleagues face greatly vary depending on where you release your product. We have created the Asia-Pac Trial Master File Summit to address this area's need for an event with a regional focus, and to share how to efficiently manage, develop and create a compliant TMF structure that meets both PMDA and global requirements.

BioProcess International Conference and Exposition

October 4-7, 2016

Boston Convention and Exhibition Center, Boston, MA, United States

BPI offers the best of both worlds - unsurpassed networking and learning offered by a large, multi-track conference and exhibition combined with informal opportunities to connect with like-minded scientific peers or customers in small group problem-solving sessions and focused discussions.

10th Annual Forum for Qualified Persons in Pharmacovigilance

October 5-6, 2016

The Crystal, London, Non-U.S., United Kingdom

This year's objectives, as shown below, build on past successes and have been shaped by valuable feedback provided by participants of the past nine meeting, plus will celebrate a decade of QPPV and Regulator interaction through this Forum. This year, there will be an enhanced opportunity for networking during a dinner at the 10th Annual Forum for Qualified Persons in Pharmacovigilance, which is included on the conference fee.

Cell and Gene Therapy BioProcessing and Commercialization

October 5-7, 2016

Boston Convention and Exhibition Center, Boston, MA, United States

Cell and Gene Therapy BioProcessing and Commercialization meeting delivers the focused science and business content designed specifically for the cell therapy and regenerative medicine fields, while providing a pivotal gathering place for connecting industry, funding sources, government and academia.

Partnerships in Clinical Trials USA 2016

October 5-7, 2016

PCT Loft at the Boston Convention and Exhibition Center, 415 Summer Street, 02210, Boston, MA, United States

Push Novel Drugs to Market through Clinical Trials Innovation, Technology and Strategic Relationships. Running for the 25th year, Dive into outsourcing, data analytics, customer service, and innovation from outside luminaries in industries thrust into dynamic and digital transformation or fresh insights and best practices to apply to your trials. Following last year's successful spotlight session on Ebola, this year's spotlight is on Zika. RandD Challenges in Finding a Cure: Lessons Learned from Running a Clinical Trial for the Zika will review how best to tackle this growing global epidemic and why rethinking traditional clinical trial processes to fast track to a cure is the leading approach.

Biorepositories & Sample Management

October 5-7, 2016

Boston Convention and Exhibition Center, Boston, MA, United States

Attend the 8th Annual Biorepositories and Sample Management Conference to examine the industry's most pressing topics, benchmark best practices with your peers, and ultimately learn how to maximize the value of your biospecimens through quality-driven biobanking This year, the theme is quality, and how the quality of your samples can determine whether you will be forced to repeat clinical trials or reproduce their results as well as the potential fallout from adverse situations. Given the diversity of biobanks in the US, from academic institutions to research institutes and hospitals, any efforts at creating regulations or governing rules for them will require more than a "one-size-fits-all" model. Join the growing community of biobankers, including global stakeholders from pharma, biotech, biorepositories, large academia, government, hospitals and research centers, to explore key topics through case studies and in-depth sessions. Topics covered include the Final Common Rule, Next Gen Sequencing, Informed Consent, Precision Medicine, Companion Diagnostics, Data & Analytics, Biobank operations, and Global Regulatory Updates, to name a few. Don't miss out on the ultimate peer-exchange event where you can turn knowledge into actionable insights! Join 150+ sample management leaders to share real-time breakthroughs and opportunities in biospecimen management-- we're all in this together!

ComplianceOnline Pharma Summit 2016 – Risk Control and Compliance

October 6-7, 2016

Venue to be announced shortly, Philadelphia, PA, United States

The ComplianceOnline Pharma Summit 2016 - Risk control & Compliance aims to bring together FDA, Experts, Leaders and Veterans to discuss the most important challenges of Biotech, Pharma industry.

Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions: 2-day In-person Seminar

October 6-7, 2016

Venue to be announced shortly, San Francisco, CA, United States

Raw material requirements in a cGMP environment are often overlooked as a company develops new products. Depending on the product being developed, e.g., tablets and capsules vs. biotechnology products, as few as fifteen to twenty or as many as sixty raw materials need to be sourced before the process can be moved from initiation through completion. This highly interactive two day seminar on raw material requirements in a cGMP environment will: Consider Health Canada, FDA, USP and EP requirements. Examine a variety of the issues surrounding raw materials to include what materials should be tested and to what extent during Phase 1, 2, 3 and commercial production. Cover testing requirements during each phase and what may be optional (regulatory risk) until the product moves to its next phase. Determine what options exist - even within a Phase 2 or Phase 3 testing framework. Discuss compendial vs. non-compendial testing and how to respond when no method is available. Discuss how a 90 percent vs. a 90.0 percent minimum purity analysis can delay initiation of testing. Explore the number of lots required for testing before reduced testing might occur and why some companies don't accept this route. Review the use of individual samples vs. composite samples for testing. Explore ASQ testing to include how to choose attributes and sample size. The objective of this two day seminar is to explore raw materials and their requirements – issues and solutions. It will also explore how water impacts the final product since water is the single largest raw material that is used within most processes. Another objective is to assure that your organization is maintaining itself within a cGMP compliance framework. Case studies to include Warning Letters will be discussed to illustrate regulatory raw material issues.

Patient-Centered Clinical Trials

October 10-11, 2016

Sonesta Hotel, Philadelphia, PA, United States

In its 3rd year eyeforpharma Patient-Centered Clinical Trials 2016 (10-11th October, Philadelphia) is the only platform to bring together a truly patient-centered dialogue between pharma and patients. This is your opportunity to join 200 of your peers for 2 days of expert presentations, heated panel discussion, interactive exhibition and exclusive networking. Hear how Bayer, Tesaro Novartis and CTTI are all making steps towards patient-centricity in clinical trials. Join all key stakeholders in clinical trials, including the patients themselves. This year’s entire agenda has been designed and shaped with the help of thousands of patient voices through a global survey and multiple in-depth consultations. This is your one stop shop to ensure your trials are optimised to be truly patient-centric. Don’t miss out, reserve your place today

European Pharmaceutical Market Access, Pricing and Reimbursement

October 10-11, 2016

Holiday Inn Kensington Forum, London, Non-U.S., United Kingdom

SMi Group’s 22nd annual European Pharmaceutical Market Access, Pricing and Reimbursement conference returns to London from 10-11 October 2016. The conference is one of the most established in the world, focusing on the changes in pricing and reimbursement and market access.

Key topics include: • Updates on AMNOG and its implication on pricing and reimbursement • How biosimilars are affecting your pricing strategy • Capture on emerging markets’ regulatory framework to adapt your market access and P&R models • Orphan drugs using recent examples to highlight the impact on pricing • Cancer drug funding and budget cuts in the UK • Innovative solutions beyond the pill • Japanese and Turkish regional updates 2016 SPEAKERS INCLUDE: • Simone Breitkopf, Head HEOR, Governmental and Public Affairs, Alcon • Ulf Staginnus, Head Market Access Oncology, Region Europe, Baxalta • Gordon Spencer, Regional Market Access Lead - EU & Canada, Shire International GmbH • Alexander Natz, Secretary General, EUCOPE • David Watson, Director of Pricing and PPRS, Association of the British Pharmaceutical Industry • Panos Kefalas, Head of Health Economics and Market Access, Cell & Gene Therapy Catapult • Ken Walsh, Senior Principal, Global Payer Strategy Consulting, Evidera 

Analytical Methods in Development and Manufacture of Drugs and Biologics: 2-Day In-Person Seminar by Ex-FDA Official

October 11-12, 2016

Venue to be announced shortly, San Francisco, CA, United States

Analytical methods ensure quality of drugs and biologics. During last 2 decades, paradigm for quality of pharmaceutical products has shifted from ensuring quality by testing representative samples to building quality during manufacture of such products, leading to the concept of Quality by Design (QbD). This course starts with discussing the new paradigm of quality, QbD, and role of analytical methods in ensuring quality. This course will go into details of the life cycle of analytical methods, including verification, qualification and validation of methods for various stages of product development and for various purposes during manufacturing operations. Appropriate methods attributes and parameters will be discussed that need to be monitored (tracking and trending) to evaluate method performance. Biologics products being complex and of biological origin, often require biological methods to release starting materials, intermediates and final product. Biological methods or bioassays with large inherent variability have challenges in developing appropriate method so that these are suitable for intended purpose. Focus on science and regulatory expectations during product development is essential to develop appropriate biological methods. This course will further go into the challenges, regulatory expectations and myths about bioassays with focus on developing suitable bioassays for intended purposes. One of the challenges in developing cutting edge products, including cellular, tissue, gene therapy products, vaccines and blood products is developing appropriate potency method for these products. Often protective mechanisms for such products or surrogate markers for efficacy of such products are not clearly defined. There are examples of use of highly variable animal based methods as potency tests, which are sometimes poor indicators of human efficacy.This course will go through regulatory expectations in developing potency tests for biological products. Critical Reagents, Reference Standards and Internal controls play an important role in ensuring validity of results generated by analytical methods, particularly biological methods, and also to ensure acceptable performance of the method over time. This course will also discuss about selection and qualification of critical reagents, reference standards and internal controls for generating reliable results. Throughout the course, specific examples with regard to achieving regulatory compliance during inspections, audits and review of methods sections, as part of license applications or supplements to license applications will be discussed. More importantly, information on the design of robust methods "Suitable for Intended Purposes" will be provided to mitigate risks of mistakes/errors and out of specification (OOS) results. At times, it may be required to modify or change a method or a specification for a product. Appropriate validations and comparability studies are required to have these changes accepted by regulatory agencies. Ways to make these changes that are acceptable to regulatory agencies and are effective in manufacturing quality products will be discussed in this course.

eyeforpharma Sydney 2016

October 11-12, 2016

ParkRoyal Darling Harbour, Sydney, Non-U.S., Australia

eyeforpharma Sydney 2016 In its 6th year eyeforpharma Sydney 2016 (11-12th October, Sydney) brings together the most innovative commercial minds from throughout the pharma industry. This is your opportunity to join 200 of your peers for 2 days of expert presentations, heated panel discussions, interactive exhibitions and exclusive networking. Join the most innovative speakers from across the Australia and AP region, including case studies from Bayer, Celgene, Pfizer, Novartis, MSD, Roche, as well as keynote presentations from the Dept. of Health and the TGA, and our out of industry specialists. Whether it’s maximising the profitability of your portfolio, delivering higher ROI from your marketing efforts or trying to build a more holistic customer experience this is your one stop shop to ensure your commercial strategy is perfected for 2017 and beyond. Don’t miss out, reserve your place today -

9th Annual Clinical Forum and Exhibition

October 13-14, 2016

Hilton Dusseldorf Hotel, Düsseldorf, Non-U.S., Germany

Clinical Data, Clinical Operations and Statistics are highly dynamic groups in the clinical development arena. Particularly 2016 will bring important changes in the European Regulatory framework once the ICH E6 Addendum kicks in. At that time ‘Quality’ is no longer the outcome of well-designed processes, but it should be an explicit and very well-considered strategy in the way we design our processes and studies. Risk-Based Monitoring will be codified in Good Clinical Practice, and many organizations will have to revisit their Standard Operations Procedures, processes and study-related documents. And obviously, this will have an impact on the roles of professionals working in clinical development.

Patients Summit Europe

October 17-18, 2016

Park Plaza Victoria London, London, Non-U.S., United Kingdom

Patient Summit Europe 2016 Now in its 13th year, the Patient Summit Europe (17th-18th October 2016, London) is the definitive meeting point for healthcare professionals who all share the same ambition – improving patient-centred care. With expert presentations from big pharma, patient advocacy groups, KOLs and real patients, this Summit brings together all key stakeholders under one roof. Over 2 days you will have the opportunity to learn, share best practise, and network with Europe’s most innovative minds in healthcare. Hear about the industry’s most ground-breaking case studies, recognise how you can take patient-centricity to the next level in your company, and prove that this business model is win-win for everyone. This is your opportunity to understand how to put your organisation on the fast track to truly productive and profitable patient-centricity. Don’t miss out, reserve your place today -

2016 PDA Universe of Pre-filled Syringes and Injection Devices

October 17-18, 2016

Hyatt Regency Huntington Beach Resort and Spa , Huntington Beach , CA, United States

At the 2016 PDA Universe of Pre-filled Syringes and Injection Devices, industry and regulatory experts will share their experiences, new developments, regulatory considerations, challenges, and industry trends and best practices. This is a must-attend event for all industry professionals involved in the development, manufacturing, testing or marketing of pre-filled syringes and injection devices.

4th Promotional Review Committee Compliance & Best Practices

October 17-18, 2016

The Madison Hotel, Morristown, NJ, United States

The leading U.S. event devoted to building the skills, speed and teamwork of your promotional review committee members will take place October 17-18 in Morristown, NJ. The 4th Promotional Review Committee Compliance & Best Practices conference is set to bring together more than 100 professionals to ensure your PRC is prepared to generate, collect and constructively act on expert comments for your entire drug and device portfolio.

7th Clinical Quality Oversight Forum

October 17-19, 2016

Hilton Philadelphia at Penn's Landing, Philadelphia, PA, United States

ExL's Clinical Quality Oversight Forum continues to live up to its reputation as an elite gathering of more than 150 senior-level executives. A meaningful exchange of ideas results from the audience's willingness to candidly share their experiences, productively discuss strategies for improving oversight, and engage with one another.

GCP Clinical Trial Audits in Practice Training and Workshop

October 17-19, 2016

Holiday Inn London Kensington Forum, 97 Cromwell Road, SW7 4DN, London, Non-U.S., United Kingdom

Inspecting or assessing clinical trials can be a challenging task. Are you 'Audit-Ready'? In this 3-day course an experienced team of auditors, EMA and inspector representatives, share detailed insights on recent updates in clinical trial legislation and guidance, electronic systems in clinical trials as well as implementation of risk management principles. A must-attend training for any professional involved in the monitoring and/or QA of clinical trials, and the supervision or coordination of clinical trial practices and quality. (Learn about what to expect and how to prepare when faced with the task of auditing clinical trials and related systems.) Why do YOUR COLLEAGUES ATTEND our GCP Trial Audit course? . Learn and apply common audit methodology principles to clinical trials in Europe and other countries . Understand how to conduct and report on trial specific and system audits . Stay up to date on the requirements for inspections . Learn how to apply a risk based approach for the planning and conduct of audits This clinical trial audit course is designed to provide training on methods and approaches to plan, conduct and report on different types of audits with examples of practical implementation and discussion of challenges. Recent trends and updates in clinical trial legislation and guidance, increased use of electronic systems in clinical trials as well as implementation of risk management principles are imbedded. The course is a combination of presentations, panel discussions and exercises by an experienced team of auditors and EMA and inspector representatives. What you will learn - Regulatory framework EU and ICH - Quality management, defining quality - Risk-based approach to audit and inspection planning and conduct - Trial system and vendor audit in practice - System audits - Communication of audit findings - Inspections by European and other authorities

The Key to Successful Health Authority Interactions HAI training

October 18-19, 2016

Hotel NH Collection Berlin, Berlin, Non-U.S., Germany

The course provides an introduction to how HAIs are organised and different types of meetings. All participants of your HA meeting delegation should attend to understand the essentials of these interactions. It also provides a good opportunity for programme leaders, project managers and other professionals who may not necessarily attend the HA meeting themselves but would need to understand the essence of HAIs. The first day of the course is perfectly suited if you or your team would like to widen or refresh your knowledge of the essentials, such as the different types of meetings, and an introduction to how Health Authorities Interactions (HAIs) are organised. The second day covers advanced topics on the strategy of approaching Health Authorities and you will acquire knowledge through role plays and discussions. You are encouraged to bring your own case studies or scenarios that will be discussed interactively with the instructors and other participants. Everyone who is a part of your HA meeting delegation should attend to ensure the whole team has a good understanding of the essentials of these interactions. It also provides a good opportunity for programme leaders, project managers and other professionals who support HA meetings, or have relevant interactions, but may not necessarily attend the HA meeting themselves, to gain a solid knowledge base on the topic successful outcome. - Understand the different types of HAIs and how to prepare for them - Get routine and confidence in formulating your questions to HAs and in compiling your briefing books - course instructors will support you in phrasing your actual questions for your upcoming HAI - Understand the necessity of a fall back strategy - Learn how to present your case, make your point and use your time at HAIs efficiently and more.. The course days can be booked separately depending on your training needs as Day 1 - Refresher Course or Day 2 - Deep Dive & Case Studies Workshop.

22nd Annual Validation Week

October 18-20, 2016

Coronado Island Marriott, San Diego, CA, United States

IVT’s Validation Week celebrates its 22nd Anniversary this year! Industry’s flagship event once again provides you the most up-to-date and comprehensive information on new global regulations, technology advances and industry case models for developing, implementing and deploying validation procedures enterprise-wide.

World CDx Boston 2016

October 18-21, 2016

Boston Convention and Exhibition Center, Boston, MA, United States

Key opinion leaders, most exciting new-comers and those looking to start harnessing targeted therapies and high-value diagnostics will come together to accelerate tailored treatments to patients in need. World CDx Boston 2016 will not only focus on the leading case studies in precision medicine but also tackle the most challenging and sobering conversations around, how far have we come with targeted therapies and companion diagnostics, the impact of precision medicine on the healthcare system and is the fit of precision medicine in drug development still a square peg in a round hole? What you can expect: • Understand the impact of biomarkers in immuno-oncology drug development to underpin the future of precision medicine in the hottest area of drug development. • Decipher the evolving reimbursement landscape for diagnostics, testing and biomarker-driven therapies to underpin your market access and adoption strategies to deliver significant return on investment. • Uncover the role of complementary diagnostics and how they inform targeted therapy selection to add this emerging approach to your precision medicine strategy. • Harness liquid biopsy methodologies for non-invasive diagnostic development and real time patient monitoring whilst demonstrating clinical utility with this approach. • Construct patient population size vs. return on investment strategy for targeted drug development in large pharma and emerging biotech’s with discussion. • Successfully navigate regulatory paradigms for targeted therapies, laboratory-developed tests, next generation sequencing and complementary diagnostics. • Incorporate biomarkers and diagnostics into early and late clinical trial designs to ensure access to the right patients in preparation for regulatory approval and reimbursement success. • Unlock the trapped potential of the data in from your biomarker-driven therapy programs, next generation sequencing protocols and multi-omic integration studies.

2016 PDA Drug Delivery Combination Products Workshop

October 19-19, 2016

Hyatt Regency Huntington Beach Resort and Spa , Huntington Beach, CA, United States

At the 2016 PDA Drug Delivery Combination Products Workshop, experts from across the drug-delivery device development spectrum will discuss the challenges they have had or are currently facing and how they’ve successfully addressed them. Interact with the participants in panel discussions on issues such as human factors, clinical studies, risk management and new challenges of design transfer, change control and FDA inspection compliance expectations.

5th Orphan Drugs & Rare Diseases Event

October 19-20, 2016

Holiday Inn Kensington Forum, London, Non-U.S., United Kingdom

Following the success of previous events, SMi's 5th annual conference on Orphan Drugs returns to London this Autumn. With a focus on the latest regulatory developments and strategies for best route to market, the conference will explore how payers, pharmaceutical, biotech and patient organisations are preparing to participate in and leverage the growing orphan drugs and rare diseases industry. Featured speakers include MHRA, Chiesi Pharma, NICE, Alexion Pharma, Mereo BioPharma, and more. Registration is now live for this unmissable CPD-certified event. Visit for more information. Early bird rates: Register by 30th June and save £400 Register by 31st August and save £200 Register by 30th September and save £100 WHY YOU SHOULD ATTEND ORPHAN DRUGS 2016: Explore the development of orphan drugs and how they prevent, diagnose and treat rare diseases Understand the industry with a focus on emerging markets and partnering with venture capitals Discuss the role of patient associations and how they are helping to fund the rare diseases field Learn strategies on defending the pricing of orphan products and how to establish a foundation for reimbursement Discover a new business model for developing rare diseases treatments Panel Discussion: How can multi-stakeholder parnterships improve the orphan drug field PLUS TWO INTERACTIVE PRE-CONFERENCE WORKSHOPS: A: Planning for success: Developing the optimal orphan drug development strategy Hosted by Cell Medica and Chiesi Farmaceutici B: Paving the way for achieving orphan drug market access Hosted by RJW & Partners

COPD: Modelling Future Needs to Adapt Your Novel Therapeutics and Management Strategies

October 19-20, 2016

Holiday Inn Kensington Forum, London, Non-U.S., United Kingdom

Chronic and with a progressive worsening characteristic, COPD could present huge problems in the developed world with the increase in opportunistic infections and long-term infections, especially it is non-curable. As such, prevention, early diagnosis and patient monitoring are the only means to tame the disease. Development of COPD has been slow despite the increase in cases. The 8th annual COPD conference will be dissecting the core issues and explore alternatives to accelerate treatment development Featured Sessions in 2016: • Predicting drug efficacy using integrative models for chronic respiratory diseases • New approaches for COPD drug development: An opportunity for disease interception • Advances in device and formulation technologies for pulmonary drug delivery Featured Speakers: • Stephen Beckman, Head of Global Respiratory and Allergy, Mylan, Inc. • Dr Neelima Khairatkar Joshi, Sr Vice President, Glenmark Pharmaceuticals • Dr Mario Scuri, Head Respiratory Unit, Chiesi Pharmaceuticals • Dr Frank Thielmann, Lead Inhalation New Solids, Novartis Pharma AG • Dr Christopher Stevenson, Venture Leader, COPD Interception, Janssen Pharmaceutical Companies of Johnson & Johnson • Dr Jonathan Phillips, Principal Scientist, Amgen • Dr Beverley Patterson, Inhalation Clinical Associate Director, Actavis • Dr Donna K Finch, Principal Scientist, MedImmune Ltd and many more

Discovery Informatics & Analytics Summit 2016

October 19-20, 2016

To Be Confirmed, London, Non-U.S., United Kingdom

Are you under pressure to reduce cycle time and drive efficiency into drug discovery and repurposing? Following extensive consultation across global pharma and biotech organisations, the need to improve current drug discovery outcomes is a well documented business imperative. With the average drug discovery cycle taking 10 years and costing upwards of $1 billion per assay, the critical need to streamline is clear. Have you harnessed advanced informatics and analytics to address these challenges? With a 97% failure rate across drug discovery, the scale of challenges in targeting, identification and compound viability have proven considerable. With the advent of machine learning, computational biology and systems pharmacology, there is now a real opportunity to effectively accelerate the drug discovery process. Significant improvements have already been made in drug retargeting and validation and industry leaders are now developing the foundations for future discovery by applying informatics & analytics principles to build data-driven decision making into the core of your discovery programme. Why attend Discovery Informatics & Analytics 2016? This is the only event specifically focused on how to apply advanced informatics and analytics to unlock scientific insights at discovery phase. Transformational strategies and techniques have already been applied at the forefront of discovery informatics, and this year's event will showcase practical use cases of how to power drug discovery using these tools. Uniting senior scientists from chemistry and biology, Discovery Informatics & Analytics 2016 offers inspirational keynote speeches, practical case studies offering immediate takeaways, interactive discussion sessions, and maximum opportunity to engage and network with colleagues from Europe and beyond.

5th European Trial Master File Summit

October 20-21, 2016

Radisson Blu Portman Hotel London, London, Non-U.S., United Kingdom

Over the last four years, ExL's Trial Master File Series has been the industry's go-to set of conferences for education and networking related to paper and electronic TMFs. The 5th European Trial Master File Summit will delve into many key topics relevant to specialists in this field. Join 100+ TMF professionals as our expert faculty explores nuances of Trial Master Files, including: eTMF processes, quality and metrics, the impact of a TMF in an MandA environment, content integration, TMF maturity, the business case for an eTMF, collaboration with a CRO, TMF completeness, quality and delivery, eTMFs and the CRO-sponsor relationship, TMF completeness and compliance, an eISF's impact on how sites manage TMFs, V3 of the TMF reference model and much more!

2016 European Pharma Market Research Conference

October 20-21, 2016

The Westin Grand Berlin Hotel, Berlin, Non-U.S., Germany

The European Pharma Market Research Conference is your exclusive entry into the world of pharmaceutical market research with a focus on Europe, yet also considering the global context of the pharma industry. It is the PREMIER event in Europe where all the industry's experts network and share knowledge all under one roof. This unique opportunity only happens once a year! Industry insiders say the European marketplace needs a fresh forum with strong industry representation where senior-level biopharma executives can gather in a comfortable environment, gain insight from premier thought leaders, explore the most critical issues, discuss best practices among peers, reconnect with old colleagues, make new contacts, and advance the profession. You'll find all that and more at this fall's European Pharma Market Research Conference!

ISPE Europe Conference on BIOTECHNOLOGY

October 24-25, 2016

Industriepark Höchst, Frankfurt, Non-U.S., Germany

Biopharmaceutical products are facing a prosperous future. The 2016 ISPE Europe Conference on Biotechnology, Reinventing Commercial Bio Manufacturing, collects novel tools in knowledge management, process science, and technological advancements to tackle these future challenges, which include: Increased competition by additional approvals of biosimilars Enhanced regulatory requirements for traceability along the process development life cycle Urgency for new technologies Solutions for process optimisation Transparency in process development We are proud to have assembled an innovative programme of highly respected speakers from regulatory, manufacturers, service providers, and academia to present best practices and case studies. Why attend? Learn about GMP challenges and opportunities for biomanufacturing Understand the implications of the new regulations, like Annex 1 and 2, for biopharmaceuticals Discuss and explore success factors of knowledge management and technology transfer in Biopharma See first-hand innovative solutions in process development Four Plant Visits options available in Industriepark Höchst at Sanofi: Multi-Insulin Plant Lantus (Insulin) Plant Cell Culture Pilot Plant for Development Höchst Industry Park Tour (History and Current Operation)

11th Annual PDA Global Conference on Pharmaceutical Microbiology

October 24-26, 2016

Hyatt Regency Crystal City , Arlington, VA, United States

At the 11th Annual PDA Global Conference on Pharmaceutical Microbiology, top industry, academic and regulatory professionals will share the latest advances and best practices for the development of standards and integration of innovative technologies that address product quality and infection control in pharmaceutical microbiology.

PMRG 2016 Institute (Pharmaceutical Market Research Group)

October 24-26, 2016

Crowne Plaza Philadelphia - Cherry Hill, 2349 W. Marlton Pike, 08002, Cherry Hill, NJ, United States

Today’s dynamic healthcare marketplace is increasingly complex: Our clients – both internal and external – are demanding more, while at the same time research dollars are dwindling. The pace and progress of innovation is breathtaking, but how do we bring that innovation and its benefits to decision makers? Introducing The 2016 PMRG Institute – The Research RoundTable In the competitive healthcare marketplace we find ourselves in today, our members are being asked to do it all – ATUs, patient audits, web-enabled qualitative interviews, and much more. What can researchers do when they are asked to employ a methodology with which they have limited familiarity? The 2016 PMRG Institute will focus on innovative techniques and technologies that enhance the capabilities of attendees and improve their ability to deliver impactful research. We’ll discuss the increasing role of partnerships and technology, and bringing insight to all of our projects. We will examine these and many more topics driven by a faculty of key thought leaders from our industry and beyond, taking full advantage of the fact that innovation within an industry often comes from outside sources. The full agenda is available now and includes a variety of peer-reviewed, fully-vetted sessions and posters, our Tuesday night awards dinner, 19+ hours of networking. This year we are also featuring Fundamentals of Marketing Research sessions for attendees new to the marketing research role and Client-led RoundTable Discussions. The 2016 PMRG Institute will give attendees the opportunity to explore and experience best-in-class industry practices from a wide array of both the traditional and novel, innovative market research methods being employed within our industry

10th Digital Pharma East

October 24-27, 2016

Loews Philadelphia Hotel, 1200 Market Street, Philadelphia, PA, United States

WHAT SETS DIGITAL PHARMA EAST APART: C-Level and Senior Management Perspective: Lacking buy-in for initiatives or a true understanding of how senior managers view the industry? Come hear multiple pharmaceutical C-level executives and presidents share their perspectives. Digital Technologies Day: Oversubscribed once again in 2015, join 250+ attendees for the premier event in digital disruption, new data, analytics technology integration and execution profiling. Harness the power of digital health as an asset for life science organizations of all sizes. Social/Innovation Day 2016: Now in its third year, attend Social/Innovation Day to learn from pairs of social media platform and life science organization representatives as they explain how partnership building, digital opportunities and business opportunity leveraging CAN take place in the highly regulated world of pharma/med devices. A Reconstructed Agenda: By providing more high-level plenary sessions in 30-minute increments and dedicated QandA interview time with our co-chairs, this year's conference contains a higher proportion of case studies, keynote presentations, fireside chats and panels. Opportunities for Team and Affiliate Divisions: Brand, Marketing, Sales, IT, Customer Excellence, Commercial Operations, Legal, Compliance and MLR departments: Embrace digital transformation and send your entire team across divisions. WHAT MAKES US THE LEADING AND LARGEST LIFE SCIENCE eMARKETING EVENT GLOBALLY: - 800+ attendees - 120+ senior-level life science speakers - 55+ keynote presentations, case studies, fireside chats, interviews and panel discussions - Presentations delivered by CEOs and presidents - The ONLY conference where you can attend the Social/Innovation Day and working lunch - Unparalleled dedicated networking opportunities over four days - Unique GLOBAL perspectives from life science experts throughout the U.S., Europe, Asia and MENA

Temperature Controlled Logistics Leaders Forum 2016

October 25-27, 2016

IQPC Ltd, London, Non-U.S., United Kingdom

The forum takes a hard look at core challenges and best practices to take your TCL strategy to the next level! Showcasing a range of case studies for you to take away practical insight and advice from leading pharma companies. We will be confronting these challenges head on enabling you to get the answers you need to transform your supply chain and help you push what is possible in temperature controlled logistics.

Current Challenges in Aseptic Processing, Potential Changes in EMA/PIC/S Annex 1 Revision

October 26-27, 2016

Hyatt Regency Crystal City, Arlington, VA, United States

The Current Challenges in Aseptic Processing, Potential Changes in EMA/PIC/S Annex 1 Revision Workshop provides a forum for industry and regulatory professionals to discuss science- and risk-based approaches that support modern aseptic processing and control strategies and will shape new regulations. It will explore the critical topics within the scope of the new revision of the EU GMP Annex 1, which will impact the future of global manufacturing of sterile medicines. Experts will discuss the most frequently raised questions in the interpretation of applicable regulations for aseptic processing and will provide recommendations for best practices for sterile product manufacturing.

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November 2016

2016 PDA Outsourcing/CMO Conference

November 3-4, 2016

Renaissance Washington, DC Hotel , Washington, DC, United States

The 2016 PDA Outsourcing/CMO Conference will showcase relevant case studies that demonstrate the importance of shared goals and partnership to bring important therapies to ever wider markets. Hear from industry leaders about their experiences in driving collaborative best practices for development and commercial execution of outsourcing partnerships.

5th Annual Cell Culture & Bioprocessing Congress 2016

November 3-4, 2016

The Radisson Blu Hotel, London , London, Non-U.S., United Kingdom

Oxford Global are proud to present the 5th Annual Cell Culture & Bioprocessing Congress, taking place on the 3-4 November 2016 at the Radisson Blu Portman Hotel in London. This Congress is an executive platform for over 170 experts to network, exchange ideas, and discuss the latest innovations in the field. Delegates come from a variety of areas, including cell line development, cell line engineering, up and downstream operations, biotechnology, process development, biologics production and more. Over 170 delegates representing leading biotech companies, global pharma organisations and internationally renowned academic institutions 50 presentations, case studies and panel discussions focused on the key issues in cell line optimisation, process development and biological production 4 interactive streams: - Cell Line Development: Stem Cells, Genome-Editing, CRISPR & NGS - Process Development - Cell Line Development: Mammalian & Bacterial Expression Systems - Biological Production 14 pre-scheduled one to one meetings, exhibition and informal networking opportunities. This Congress is an executive platform for over 170 experts to network, exchange ideas, and discuss the latest innovations in the field. Delegates come from a variety of areas, including cell line development, cell line engineering, up and downstream operations, biotechnology, process development, biologics production and more. On Day One, the conference will address stem cell development, gene-editing, cell genome NGS sequencing and CRISPR technology. Our expert speakers will discuss technologies for precise genome editing as well as the potential uses gene editing could have in future, how to ensure quality of raw materials in stem cell culture, and 3D cell culture technologies. Key issues to be covered in our Process Development stream include novel single use technologies, analytics development and the processing of Bispecific antibodies. Day two of the event will see our leading industry and academic speakers present subjects such as the optimisation of cell lines, contamination issues in manufacture, efficient technology transfer, strategies in the use of Quality by Design, and the future of continuous processing. Other key topics that delegates will have the opportunity to hear about include first hand experiences from speakers of biosimilar cell line development, and innovation in the early development of bispecific antibodies. Our cell line development stream will have a focus on innovation in the use of both mammalian and bacterial expression systems.

Well Characterized Biologicals

November 3-4, 2016

The Westin Arlington Gateway, Arlington, VA, United States

Well Characterized Biologicals is the industry's most trusted and longest running event to gain the regulatory guidance and analytical characterization strategies you need to ensure accurate CMC submissions.

The First International Congress on European Regulations and Compliance for Cosmetics (CRCC2016)

November 7-8, 2016

Hilton Prague Pobrezni 1 186 00, Prague Czech Republic, Prague , Non-U.S., Czech Republic

Dear Colleague, It is our pleasure to invite you to participate in The First International Congress on European Regulations and Compliance for Cosmetics (CRCC2016), which will take place 7-8 November 2016, at the Hilton Prague in Prague, Czech Republic. This first congress will address areas of regulations and compliance in an exciting and informative manner. With world renowned speakers secured to present groundbreaking news, CRCC2016 will be a congress to be remembered & definitely not to be missed. Topics to be covered, among others will be: -European Regulatory Framework -Implementation of Regulations -Skin Irritations -Regulated Substances -SCCS Guidelines Join the Congress and benefit from expanding your network. Meet new friends, greet old colleagues and discuss new insight gained. We look forward to welcoming you to CRCC2016 in the exciting and historical city of Prague.

Global Conference on Pharmacy and Pharmaceutical Sciences Education

November 7-8, 2016

Purple Palace Nanjing Hotel, Nanjing, Non-U.S., China

This unique conference will gather pharmacy leaders, policymakers and regulators from across the globe to set the future milestones for education and workforce development of pharmacists and pharmaceutical scientists. The International Pharmaceutical Federation (FIP) is proud to host this seminal platform to establish dialogue and consensus among the international community on how pharmaceutical workforce competence can be assured through transformative education. FIP will lead the adoption of a clear roadmap on which all stakeholders can rely to advance education and training through a shared vision to accept fully responsibility and accountability for improving global health.

Lab Automation & Robotics 2016

November 8-9, 2016

Maritim proArte Hotel, Berlin, Non-U.S., Germany

Following last year’s successful event in Hannover we move to Berlin for 2016. Lab Automation & Robotics 2016 is an industry forum where lab professionals and engineers can share best practice and innovations in this fast moving field. Novel hardware, components, software, changing standards and case studies will be addressed in both lectures and round table discussions. Other topics within the agenda will be: Applications of Automation and Robotics in: Analytical Laboratories Biobanking & Biorepositories Genomics Research The agenda is available to view online. To ensure the best learning experience and networking opportunities, registration fees have been kept to a nominal level. SELECTBIO is offering a limited number of student bursaries for this event, visit the website for more information. You can present your research on a poster while attending the meeting. Poster Submission Deadline: 14 October 2016.

2016 PDA Data Integrity Workshop

November 8-9, 2016

Titanic Chaussee Berlin, Berlin, Non-U.S., Germany

The 2016 PDA Data Integrity Workshop, offered several times in global locations, will explore the multiple facets of data integrity, such as quality culture, human behavior, training needs and technology requirements. Through case studies, presentations and breakout sessions, this interactive, must-attend event will help you learn implementable, best practices for preventing, detecting, mitigating and remediating data integrity issues.

4th European Biosimilars Conference

November 9-10, 2016

Hotel Pullman Brussels Midi, Brussels, Non-U.S., Belgium

Biosimilar medicines' developments are maintaining their momentum and the 2016 Biosimilars Conference programme delves into strategic discussions regarding: Market and regulatory developments in the EU and globally, enlightened by the perspective of healthcare professionals' and patients' experiences Pharmacovigilance and clinical practice - what can be learned from the emerging data? The impact of biosimilar medicines on the competitive landscape of biological products, in light of 10 years of market existence As the 4th conference of its kind, the 2016 programme gives a complete 360-degree overview of biosimilar medicines. Participants will leave the conference with a wealth of new information and an expanded network of contacts. Featured topics Current regulatory status of biosimilar medicines in the EU and beyond Biological medicines in practice - experiences and views of patients, pharmacists, nurses, physicians and hospital managers/ payers (procurers) Key learnings from multi-stakeholder dialogue platforms on patients and healthcare professionals' information needs The balance of risk and benefits for biosimilars – where it stands after a decade of biosimilar use Interchangeability and switching of biosimilars Clinical experience and real world evidence for biosimilar medicines: what is the state of play in terms of clinical and economic value proposals What you will learn Deal with regulatory requirements, scientific and operational challenges Exchange experiences and discuss hot topics with experts Update the participant on the current knowledge including regulatory and scientific thinking Discuss the necessary conditions for optimal use Who should attend? Regulatory affairs professionals Healthcare professionals Patient advocates Regulators Decision makers

2nd Annual Genome Editing Congress 2016

November 10-11, 2016

Novotel West London, London, Non-U.S., United Kingdom

Oxford Global Conferences are proud to announce the 2nd Annual Genome Editing Congress, taking place on 10-11 November 2016 at the Novotel London West in London, UK. This highly anticipated event provides a unique opportunity for over 450 senior level experts to engage in scientific discussions about the current research results and latest advancements that help the industry going forward. The genome editing market represents a rapidly evolving area of pharmaceutical research since the discovery of the CRISPR/Cas systems that have revolutionised biological research. Significant advancements have been made in the fields of improving genome editing tools & technologies, gene delivery systems and utilising genome editing for therapeutic applications. Genomics research is experiencing an increased funding and thanks to the technological advancements the genome editing market is expected to grow rapidly. Experts have also highlighted that the global market for genome editing is expected to reach over $2.0 billion by 2020. On day one our esteemed speakers will focus on topic areas covering genome editing techniques. Presentations will focus on the latest developments and novel methods for genome editing and engineering as well as advancements in gene editing systems. Genome editing using CRISPR, TALEN & ZFN systems and utilising genome editing in drug discovery and development will also be covered. On day two delegates will have the unique chance to hear presentations on the therapeutic applications of genome editing. Our highly distinguished speakers will deliver case studies from cardiovascular diseases, diabetes, genetic disorders and gene therapy. Key opinion leaders will also address updates in novel genome engineering methods and improving genome targeting precision.

8th Annual Next Generation Sequencing Congress 2016

November 10-11, 2016

Novotel London West, London, Non-U.S., United Kingdom

Oxford Global Conferences are proud to present the 8th Annual Next Generation Sequencing Congress, taking place on 10-11 November 2016 at the Novotel London West in London, UK. This highly prestigious event provides a unique opportunity for over 450 senior level experts to network about the current landscape of the industry and to facilitate high level scientific discussions in order to help the market going forward. The next generation sequencing market represents a rapidly moving area of research. The industry is characterised by continuous improvements and developments aimed at affordable costs, improved efficiency & accuracy. Advancements in NGS technologies and platforms, improved NGS data analysis techniques as well as novel bioinformatics tools all underpin the industry’s unquestionable potential. It has also been highlighted that the global next generation sequencing market will reach $27.8 billion by 2022. On day one this year’s revamped programme will cover advances in next generation sequencing platforms and key therapeutic applications. Presentations will extend to such vital research areas as improvements in DNA, RNA & protein sequencing technologies, latest gene editing techniques in NGS as well as case studies from utilising NGS in medicine and therapeutics. A separate stream will be devoted to hot topic areas in NGS data management and bioinformatics. Delegates will have the unique opportunity to join discussions about the developments in NGS analysis technologies, integrating ‘omic’ data sets and Big Data and cloud computing strategies in NGS. On day two highly distinguished speakers will address NGS clinical applications and diagnostics. Such key topic areas will be covered as case studies of using next generation sequencing in the clinic, novel technologies and platforms to analyse NGS data and integrating data sets. NGS for precision & personalised medicine will also be covered.

4th Annual Single Cell Analysis Congress 2016

November 10-11, 2016

Novotel London West, London, Non-U.S., United Kingdom

Oxford Global are delighted to announce the highly anticipated 4th Annual Single Cell Analysis Congress, taking place on taking place on 10 – 11 November 2016, in London, UK. This unique event will feature presentations covering exciting single cell ‘omics case studies, success stories from different therapeutic areas as well as overcoming bioinformatics challenges. The event will welcome over 450 senior-level delegates from not only the single cell, but also from next generation sequencing and genome editing areas. The single cell analysis market represents a very exciting area of research that is rapidly evolving. It is forecasted to become a very powerful market thanks to the continuous developments in singe cell analysis technologies and applications as well as novel strategies to overcome complex challenges in sample preparation, bioinformatics and data analysis. Co-located with the highly established 8th Annual Next Generation Sequencing Congress and 2nd Annual Genome Editing Congress, our event provides a unique opportunity for experts engaged in the above areas to network with esteemed Professors and Directors from leading academic and research institutions such as George Washington University, Weizmann Institute of Science and University of Helsinki. Key presentations will include molecular insights into circulating tumor and trophoblastic cells, presented by Patrizia Paterlini-Bréchot, Professor of Cell Biology, Paris Descartes University and droplet-based microfluidics for single cell analysis by Valerie Taly, Group Leader and CNRS Research Director, Paris Descartes University. For the latest conference updates follow us on Twitter @xgenseq and join the congress conversation on #xgenseq16. For registration details contact

Life Sciences Ingredients

November 10-12, 2016

Istanbul Expo Center, Istanbul, Non-U.S., Turkey

Pharmaceuticals, Food, Cosmetics, Personal and Home Care Ingredients, Raw Materials and Technologies Exhibition: 'Life Sciences Ingredients 2016' “Life Sciences” has become one of the most important industries as it comprises the fields of science that involve everything about humans and life. With its fast growing economy, Turkey and Istanbul has been an attraction center for many international companies who operate in Pharmaceuticals, Food, Cosmetics, Personal and Home Care Ingredients Industries and seeking opportunities to penetrate in Turkey and surrounding markets and supply commercial goods by participating in successful exhibitions. “International Chemical Industry Group Exhibition” Chem Show Eurasia which is a globally renowned and followed exhibition will befeaturing “Life Science Ingredients Show” in 2016. Life Sciences Ingredients 2016, which comprises all components of life, will be held concurrently with Chem Show Eurasia which is the largest and most comprehensive meeting point of the Chemical Industry in Turkey and Eurasia, by gathering the companies operating in the fields of Pharmaceuticals, Food, Cosmetics, Personal and Home Care Ingredients, Raw Materials and Technologies between 10-12 November 2016.

2016 AAPS Annual Meeting and Exposition

November 13-17, 2016

Colorado Convention Center, Denver, CO, United States

Since 1986, the AAPS Annual Meeting and Exposition has been delivering the science and tools that move you forward in your career. Featuring the largest gathering of scientists involved in the discovery, development, and manufacture of pharmaceutical products and therapies, you will engage with experts in meaningful ways.

Scientific Program Themes

This year, the Annual Meeting Programming Committee has identified themes that will have an impact in how you work and collaborate. Full programming streams have been created in order for attendees to take a deep dive or skim the surface of these forward-looking topics:

  • Advancing Product Development through Novel Technology: Material Science, Engineering and Analytical Methodology
  • Making New Delivery Modalities a Reality: Peptides, Proteins and Conjugates
  • Enhancing Patient Lives through Accelerated Drug Development
  • Paving the Way for Precision Medicine: Innovation and Implementation

For more information and to register, click here.

World Precision Medicine Congress USA 2016

November 14-15, 2016

Hyatt Regency Washington on Capitol Hill, 400 New Jersey Avenue NW, Washington, DC, United States

Precision medicine has the potential to cure diseases previously thought incurable. It has the potential to enhance the quality of life for millions of patients around the world who traditional medications simply aren’t working for. It has the potential to eliminate side-effects as each drug is tailored to a specific subset of individuals. Even President Obama showcased his belief in the potential when he announced the Precision Medicine Initiative (PMI) through the NIH. The question is, how do we get there? Answering this is why we decided to develop the World Precision Medicine Congress USA in Washington, D.C. for 2016. This event is bringing together big pharma, big data, and healthcare providers to discuss the scientific, economic, and policy goals towards producing precise and genomic-based medicines. Partnered with forward-looking industry leaders such as NantWorks, this event will fast-track our momentum into the future paradigm of healthcare by spurring the important discussions to get us there. Both the scientific and the business challenges will be represented.

World Biosimilar Congress 2016

November 14-15, 2016

Congress Center Basel, Messeplatz 21, 4058, Basel, Non-U.S., Switzerland

In 2015, we saw the crescendo of the Amgen versus Sandoz case after many months of appeals. Along with that legal case, many more are still ongoing in the biosimilar sector. This year also provided a milestone in the ongoing discussions and debates on naming conventions with both the US FDA and WHO providing their individual guidance on such issues.

World Immunotherapy Congress 2016

November 14-16, 2016

Congress Center Basel, Basel, Non-U.S., Switzerland

Immunotherapy currently offers the brightest hope for cancer treatment. New developments with checkpoint inhibitors and co-stimulatory targets have enabled some stunning breakthroughs and high optimism for the sector. Recently, there have been some incredibly exciting new therapies in areas such as CAR-T and Oncolytic Viral Immunotherapy. Our vision is to bring together the full community and provide a single meeting point for the whole value chain. It is where science meets business to make immunotherapy the cornerstone of the fight against cancer. The event is new, though the ideas and relationships are not. The event comes out of our discussions with leading clinicians, pharmaceutical companies, biotechs and research institutes held every year at the successful European Antibody Congress, now in its twelfth successful year.

Biopharma India 2016

November 15-16, 2016

Hyatt Regency, Sahar Airport Road, 400 099, Mumbai, Non-U.S., India

The move towards a more transparent regulatory regime in India is opening up its biopharma industry once again. With the widely available patient population and low manufacturing cost base, India remains an attractive destination for international biopharma players. But there are still challenges - quality assurance and control concerns need to be addressed if India wants to supply into the world’s most lucrative international markets. RandD also needs to be strongly supported, fostering an environment of innovation and encouraging new biotech start-ups to develop cutting-edge solutions and products. If we can tackle these challenges, India’s biopharma opportunity will be extraordinary. Welcome to BioPharma India 2016. This November, together with leading biotech entrepreneurs, innovative start-ups and major pharma players from both within and outside India, BioPharma India will offer a brand new perspective to stakeholders on how you can leverage India’s strength to be a major player in the global biopharma market. BioPharma India isn't a trade show. We bring senior executives together to explore the most exciting opportunities India’s biopharma industry has to offer. With case studies, innovation showcases and interactive panel discussions, you can hear from the movers and shakers and then meet them. If you are part of India's biopharma ecosystem, or want to be, then you need to join us at BioPharma India 2016

Biosimilars North America

November 16-17, 2016

Renaissance Woodbridge Hotel, Iselin, NJ, United States

Following the first approval of biosimilars in the US, FDA has received even more applications and the industry is expecting 2 more products receiving the green light this year. Nonetheless, the recent Remicade case between Celltrion and JandJ has also casted doubts amongst market participants. The 3rd annual Biosimilars USA conference will return in November to discuss the following topics in such evolving market landscape: Examine the latest biosimilar applications and cases Evaluate the global biosimilars market and assist delegates to define the optimal penetration strategy Reveal latest regulatory and legal updates to ensure smooth approval and licensing process Debate how to de-risk and develop a holistic value chain for biosimilars commercialization Define post-launch and marketing plan: What are the distribution channels? Portfolio and branding strategy of biosimilars: How should we build a sustainable business model? Assess technological breakthroughs to speed up characterization and drug development programs Understand rationale behind pricing and discount - engage with your payers Chairman: Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals USA, Inc. Elite Speaker Panel 2016: Edric Engert, Senior Vice President, Biosimilars, Teva Pharmaceuticals Gustavo Grampp, Ph.D., Director RandD Policy - Biosimilars, Amgen Inc. Hillel Cohen, Executive Director, Scientifi c Affairs, Sandoz Andrew Simpson, Scientifi c Director, Orygen Biotechnologia S/A Dr. Jianguo Yang, CEO, Abpro-China; Vice President, Abpro-US Daniel Alvarez, Senior Director, Asset Lead, Global Established Pharma, Pfi zer Inc. PLUS TWO INTERACTIVE HALF-DAY PRE-CONFERENCE WORKSHOPS A: Leveraging Successful Patient Recruitment and Retention Strategies in Biosimilars Research (UBC - An Express Scripts Company) B: Biosimilars: Considerations for Optimizing Access and Price (MKTX Market Access Solutions, LLC)

Understanding Sterilization Methods for Products and Devices

November 16-17, 2016

The Desmond Hotel and Conference Center, Malvern, PA, United States

The course provides a basic but comprehensive presentation of sterilization procedures as they are used in the pharmaceutical and medical device industries.After you complete this course you will understand how and why specific sterilization methods are used in particular applications, how the methods are validated, and the strengths and weaknesses of different methods. You will understand what equipment is used in sterilizations, sterilization cycle development, sampling of products for sterility, and sterility assurance.You will also be presented with the latest developments in the microbial monitoring techniques used in sterility estimations. An extensive appendix providing detailed discussions of some sterilization topics and scientific literature references is included with the course notes. The purpose of the appendix is to provide supplementary material for attendees who wish to go deeper into specific aspects of sterilization after the course.

RPM Expo 2016

November 17-17, 2016

DoubleTree Hotel, Somerset, NJ, United States

RPM Expo is a marketplace for manufacturing engineers, managers, and front line operators to learn about emerging solutions to the complexities of pharmaceutical manufacturing: automation, biologics, small molecules, generics, biosimilars, process engineering, single use, continuous process, regulatory and supply chain concerns.

Bioelectronics and Biosensors Congress 2016

November 17-18, 2016

To be announced, London, Non-U.S., United Kingdom

Oxford Global Conferences are proud to present Europe’s leading Bioelectronics and Biosensors Congress, taking place on the 17-18 November 2016 in London. Our event features over 35 international world-class speakers who will share their research into biomedical electronics, nerve stimulation, implantable devices and neuromodulation devices. 150 delegates from world renowned academic institutions, global pharmaceutical organisations and innovative biotechnology companies 36 presentations and case studies focusing on the key developments in bioelectronic devices, diagnostic sensors, nerve stimulation, implantable devices and ‘electroceuticals’ 4 interactive streams: - Driving the Industry Forwards – Regulatory Updates, Commercial Partnerships and a Focus on Basic Science - Bioelectronics – Development Challenges and Opportunities - Therapeutic Potentials of Bioelectronics and Clinical Applications and Results so Far - Biosensors – Development Challenges and Opportunities. As much as we think of the human body as a biological entity, bioelectronic and biosensor devices remind us that our electrical components are equally as key. Bioengineers have long been exploring how to understand, harness and manipulate the electrical charges in the body, and with increasing collaboration with neuro-engineers and data analysts bioelectronics looks poised to be one of the key medical industries of the 21st Century. This event provides an ideal platform to participate in formal 1-1 meetings and informal networking drinks with other key industry figures, as well as providing opportunities to exchange ideas with some of the most influential professionals in the field.

Mena Pharmaceutical Manufacturing Congress

November 29 - December 1, 2016

Le Meridien , Jeddah, Non-U.S., Saudi Arabia

MENA Pharmaceutical Manufacturing Congress will set a unique platform by gathering the pioneers from the local and international pharmaceutical companies; CEOs, plant managers, production managers, supply chain managers, quality assurance managers, regulators affairs, and managers. In addition to the leading technology providers who will showcase the latest technologies in pharmaceutical manufacturing. The congress will include case studies, presentations, interactive panel discussions focusing on the obstacles fronting the pharmaceutical industry, the integration between the different concerned entities, and the future of the industry in the region; as well as an exhibition featuring the latest machineries used during the different pharmaceutical manufacturing stages, raw materials suppliers, and more.

ManuPharma 2016

November 30 - December 1, 2016

 The Westin Grand Frankfurt, Frankfurt, Non-U.S., Germany

Europe's first peer-led pharma event for Heads of Tech Ops, Heads of Manufacturing Ops and Site Leads.

ManuPharma 2016 provides you with a “how to” guide to transform your manufacturing strategy to best meet changing product portfolio, regulatory and customer requirements.

Join us for this year’s best opportunity to benchmark on how other companies are embracing industry disruption and achieving success with disruptive technologies (industry 4.0, IoT, additive manufacturing), data integrity, MES, QbD, PAT, sterile manufacturing fill + finish and Continuous Manufacturing.

We understand your challenges, and have designed the agenda to help you to find out how to implement advanced manufacturing technology and benchmark your sites and systems. Through exchanging ideas with senior-level peers in our interactive round-tables and workshops you will be able to discuss your personal manufacturing challenges.

ManuPharma really is the most senior-level, bespoke event for the pharmaceutical manufacturing industry - whether you are at VP or Director level, if you specialise in manufacturing ops, tech ops, or leading a site.

Download the agenda:

Use our exclusive code – PHARMAN15 - when booking online to save 15% -

Chemspec South East Asia 2016

November 30 - December 1, 2016

Queen Sirikit National Convention Center, Bangkok, Non-U.S., Thailand

Chemspec South East Asia 2016 will be held in Bangkok, Thailand, from 30 November – 1 December 2016. The show profiles also covered agrochemical, pharmaceutical, cosmetics, petrochemical, food ingredients. The Chemspec South East Asia - Thailand exhibition will provide a platform for the industry across the ASEAN region and beyond, to meet, trade, discuss and develop performance chemical supplies for the region. One of the strengths of Chemspec exhibitions is to enable suppliers to arrange meetings with key buyers in a structured, confidential and professional environment. This will be the focus of the South East Asia edition in 2016.

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December 2016

Water Purification Systems for Regulated Industries - Design, Chemistry and Validation

December 5-6, 2016

The Desmond Hotel and Conference Center, Malvern, PA, United States

The course consists of interactive lectures, discussions, and imbedded exercises. Participants will also be placed in several real life situations where they complete a compliance review of a schematic process flow diagram, analyze failures using trend reports, critique a risk assessment, and perform a change control analysis including the impact of requested or proposed modifications. The course is designed to provide the attendee with a practical understanding of the following topics: •Basic water chemistry •Water quality selection criteria •EPA, EU, and WHO drinking water standards •The governing regulatory agencies with direct impact on water systems •Analytical water grades (1, 2, 3) and reagent water types (I, II, III, IV, with A, B & C subgroups) •Pharmacopeia water grades (Purified, Highly Purified, Water for Injection & Clean Steam) •Pretreatment component equipment - selection and operating principals •Final treatment options (reverse osmosis, vapor compression, single-effect and multiple-effect stills) •Opportunities for energy and water resource conservation •Point of use criteria such as temperature, location, time-of-day, and demand (GPM & GPD) •System design including materials of construction, generation, storage and distribution options •Trend reports (analysis, problem identification, predictive value) •Control systems, data historian, secure access, set points and alarms •Managing performance deviations and component failure •Direct and in-direct impact analysis •Quality by design including risk assessment •Instrument calibration for critical, non-critical, and informational only devices •Maintenance impacts to system performance, reliability, and validation •The importance of as-built documentation - user and field directed changes

Clinical Trial Regulation Workshop

December 6-7, 2016

Amba Hotel Marble Arch, London, Non-U.S., United Kingdom

While publication of the Clinical Trial Database is delayed, the endorsement of the Clinical Trial Regulation is moving forward in other areas. The Clinical Trials Forum will focus on the differences between, the present and new requirements on managing clinical trials in the face of forthcoming changes. This 2-day workshop will provide a forum for information exchange on both conceptual and practical questions of: - How will the new legislation change the processes and the format of the trial application? - What are the impacts on how a clinical trial is managed after approval has been granted? - What are the critical issues affecting sponsors and Member States as they consider changes needed to implement the regulation? - How will the new provisions for public access to an EU Clinical Trials Database enforce disclosure of clinical trial data and information? Attendees will participate in the collaborative discussions through lectures, panel discussions and interactive sessions. Learning objectives - Understand the new requirements along with the practical and operational considerations for implementation by authorities and clinical trial sponsors - Identify the key challenges and opportunities of the new requirements and policies - Leverage insights on how companies and research institutions are fine-tuning and optimising - processes to meet the requirements of the Clinical Trials Regulation - Exchange views between regulators, clinical trial sponsors, patients, and other stakeholders The course is suitable for people working in the pharmaceutical industry and contract research organisations, from clinical science and clinical operations Monitors, auditors of clinical trials, Regulatory affairs personnel, and Pharmacovigilance staff.

2016 PDA Data Integrity Workshop

December 7-8, 2016

Manchester Grand Hyatt , San Diego, CA, United States

The 2016 PDA Data Integrity Workshop, offered several times in global locations, will explore the multiple facets of data integrity, such as quality culture, human behavior, training needs and technology requirements. Through case studies, presentations and breakout sessions, this interactive, must-attend event will help you learn implementable, best practices for preventing, detecting, mitigating and remediating data integrity issues.

Clinical Trial Disclosure and Data Transparency Workshop

December 7-8, 2016

Amba Hotel Marble Arch, London, Non-U.S., United Kingdom

Transparency of clinical trial information is taking on new dimensions, including the release of anonymized participant-level data and return of results to study participants. Clinical trial sponsors and academia are facing a host of new registration requirements in the EU and the US. There is a call to share their clinical trial data and industry's initiatives on data sharing are also expanding. This increased transparency and use of information from clinical trials brings with it new data use opportunities and operational challenges for industry and academia. The continuing expansion of disclosure requirements in the US and EU leave many sponsors and academia considering disclosure strategy, developing operational measures, and looking for efficient ways to manage dissemination of clinical trial protocol information and results data. The users of clinical trial information is varied which provides both opportunities and challenges for how the information is provided. Learning objectives Learn about the latest developments relating to the EU Clinical Trial Regulation and its impact on transparency, and trends in the global clinical trial disclosure world Benefit from the various perspectives on clinical trial transparency of large, mid-sized, and smaller sponsor organizations Leverage best practices on implementation of clinical trial disclosure through case studies by exchanging views between regulators, industry, patients, academia and other stakeholders

Heating, Ventilation, and Air Conditioning (HVAC) in a Regulated Environment

December 7-9, 2016

The Desmond Hotel and Concerence Center, Malvern, PA, United States

This is a three-day course designed to provide individuals with an in depth understanding of the design, balancing, commissioning, operation and maintenance of HVAC systems in a regulated environment. The course consists of lectures and imbedded exercises. Participants will also be placed in several real life situations such as completing a compliance review of floor plans and air flow diagrams, room pressurization schemes, ductwork design, and air balance reports; conducting emergency egress analysis during a system failure; HVAC risk assessment; and change control analysis including the impact of modifications requested by the end user. The course is designed to provide the attendee with thorough knowledge of the following topics: •The governing regulatory agencies with direct impact on HVAC systems •FDA and EU classified space comparison •What constitutes Good Engineering Practice •The major components of an HVAC system •A high level overview of Psychrometrics •The engineering and design process •Latent and sensible loads •Types of systems – application and operation •Energy conservation measures and their impact on system performance •Ventilation requirements •Control set points and alarms •Air balancing – cascading air flows and room pressurization •Risk assessment for HVAC •Air filtration – from bird screens to terminal HEPA filters •Sources of air particle contamination •Room air-change rates – ISO standards •Room recovery period versus air change rates •Sterility versus containment •Humidity and temperature set points – range of control and tolerances •Instrument calibration – critical, non-critical, and informational •Maintenance impacts to system performance, reliability, and validation •Partnering with the system owner to obtain funding for major repairs, upgrades or wholesale replacement •Personnel safety and egress considerations •The importance of as-built documentation – user and field directed changes •The engineering turnover package (ETOP) and commissioning

Understanding the Statistical Considerations for Quantitative ICH Guidelines: 2-Day Hands-on Workshop

December 8-9, 2016

Venue to be announced shortly, San Francisco, CA, United States

Course Description: This course is designed to introduce to individuals the understanding and interpretation of the statistical concepts with reference to certain quantitative ICH Guidelines that apply across laboratory (drug development) and clinical development (drug/device) procedures such as analytical methods in validation and acceptance criteria in calibration procedures, risk management and process monitoring as well as dealing with uncertainties and other relevant issues. It is not a course in statistics but introduces the participant to a hands on approach to the statistical techniques one uses, how they are applied and reasonably interpreted and understood. One will address the various challenges facing pharmaceutical and biotechnology companies when it comes to quantifying results in a meaningful interpretable manner through tabulations and graphical presentations. In this two day workshop seminar one will learn the different regulatory agencies expectations of the quantification and development of a sound statistical monitoring of process control that are accepted, effective, and efficient. Participants will become familiar with the important aspects of the statistical methods and learn how organizations are expected to apply these guidelines.

11th annual Cold Chain Distribution

December 12-13, 2016

Park Plaza Victoria, London, Non-U.S., United Kingdom

Following the fruitful discussions in 2015, SMi's annual Cold Chain Distribution conference will bring back lively debates and industry updates to London, offering the best platform for delegates to stay ahead of this lucrative market! Benefits of Attending:

  • Hear from MHRA, PIC/S and Danish Medicines Agency on GDP updates to ensure compliance
  • Insights into emerging markets for cold chain distribution potential and challenges
  • Learn about the latest technologies in cold chain distribution, from temperature monitoring to packaging
  • Practical case studies - how to execute the last mile distribution and what are the new strategies to implement seamless cold chain distribution?
  • Evaluate your logistics planning with you 3PLs to drive operational excellence

Confirmed Speakers for 2016 Include:

  • Steve Todd, Senior GDP Inspector; Chair of GDP Expert Circle, MHRA
  • Andrea Gruber, Senior Manager, Special Cargo, IATA
  • Didier Basseras, Vice President, Global Head of Clinical Supplies - Clinical Supply Chain, Sanofi-Aventis
  • Gino Vleugels, Senior Manager EMEA Temperature Control, Johnson & Johnson
  • Yoram Eshel, Senior Director, Global Transportation and Logistics, Teva Pharmaceutical
  • Stephen Mitchell, Quality & Compliance Manager, Global Logistics, GSK
  • Saddam Huq, QA Senior Manager, Global Logistics & Cold Chain, GSK Biologicals
  • Thomas Vestergaard Pedersen, Medicines Inspector, Danish Medicines Agency
  • Tony Wright, CEO, Exelsius
  • David Spillett, Business Development Manager, World Courier
  • Fredrik Wildtgrube, Head of Global Sales, Finnair Cargo
  • Tim Holliday, Qualified Person, PCI Pharma Services
  • Mark Edwards, Managing Director, Modalis

and many more.

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January 2017

Pharmaceutical Microbiology

January 18-19, 2017

Holiday Inn Kensington Forum, London, Non-U.S., United Kingdom

SMi proudly presents the return of the 6th annual Pharmaceutical Microbiology conference to London in 2017! The microbiology market has significantly grown in recent years as the demand from end user industries increases. With this expansion and increased demand comes hurdles for the industry. SMi’s 6th annual Pharmaceutical Microbiology conference will address the complex challenge that the field is facing such as endotoxin testing, best practices in cleaning & disinfection and contamination control case studies. The comprehensive agenda will include presentations from both regulatory and industry experts sharing recent case studies and developing trends in the field of pharmaceutical microbiology. Expert speaker line-up includes: Sanofi Pharma, Bristol Myers Squibb, MHRA, Merial Sas, GSK, Shire Laboratories, Sanofi Pharma, and many more. For further information please get in touch with Matthew Apps on +44 (0) 207 827 6093 or or visit

GMP requirements for quality control and contract laboratories 2016

January 23-24, 2017

The Leela Mumbai Andheri Kurla Road, Sahar Village, Andheri-Kurla Road, Mumbai, Maharashtra 400059, Mumbai, CA, United States

Overview: Quality control and related contract laboratories are considered at high risk because after testing and approval, drug products and Active Pharmaceutical Ingredients (APIs) are released to the market without further check. That's the reason why the FDA and other agencies put highest emphasis on inspections of QC laboratories. Even though cGMP regulations have been in place since long time, the large number of QC related 483's and warning letters demonstrate that companies have problems with implementation. This two day interactive in-person seminar will provide participants the regulatory background and guidelines through all critical areas of GMP compliance. This course helps attendees understand the latest requirements and also provides them templates and examples to develop inspection ready documentation. Practical examples and interactive exercises will be dispersed into and between the presentations while 50% of the total time will be dedicated to practical sessions. During the seminar, participants will work in small groups on case studies and prepare the answers using prepared fill-in templates. After the course a large variety of tools such as SOPs, validation examples and checklists will be readily available on a dedicated website that can be used to easily implement what they have learned from the course. Learning Objectives: • Learn about the regulatory background and GMP requirements for quality control and contract laboratories. • Understand and be able to explain your company's quality plan or laboratory compliance master plan. • Understand the difference between GMP and non-GMP laboratories. • Learn how to develop inspection ready documentation. • Be able to train others in your organization on GMP requirements. • Learn how to avoid and/or respond to the FDA inspectional observations and warning letters. Complimentary Hand-outs: For easy implementation, attendees will receive free access to "Laboratory Compliance Package" as Web download. This package includes 46 SOPs, a compliance master plan, checklist and templates that help to implement GMP requirements in laboratories • 50-Page primer: FDA GMP Compliance in Analytical Laboratories • Laboratory Compliance Master Plan • Worksheet - Laboratory Audits • Following Standard Operating Procedures: Agenda: Day 1 Schedule: Lecture 1: FDA Regulations and Requirements Overview • FDA 21 CFR Part 211 and 21 CFR Part 11 • Most frequently cited FDA 483s and warning letters • Requirements overview from sampling to archiving • Quality system requirements, e.g., ICH Q10 • The concept and practice of risk based compliance Lecture 2: Planning for quality and cGMP compliance • Developing and using a validation master plan • Scope, objectives and key elements of the master plan • Developing and using FDA compliant SOPs • Using templates to generate inspection ready documentation • Planning for efficiency cost-effectiveness Lecture 3: Calibration and Qualification of Laboratory Equipment • FDA requirements • USP chapter for instrument qualification • Going through examples for qualification steps(DQ, IQ, OQ, PQ) • SOPs and deliverables for three instrument categories • Developing calibration and qualification protocols Lecture 4: Equipment Maintenance and Change control • Preventive maintenance; tasks, documentation • Planned and unplanned changes • Changing hardware, firmware, documentation • Definition and handling of like-for-like changes. • Requalification: time and event based Lecture 5: Validation of Laboratory Computer Systems • Going through the new GAMP® guide: "A Risk based Approach to Laboratory Computerized Systems" • Going through a complete laboratory computer system validation from beginning to end • Integration the GAMP® guide with USP • Periodic evaluation to reduce revalidation efforts • Revalidation: why, what, when Lecture 6: Validation of Analytical Methods and Procedures • Parameters and tests according to ICH Q2 • Developing a validation plan, protocols and a report • Setting acceptance criteria for different applications • Verification of compendia methods according to USP • Transfer of analytical procedures according to the new USP Day 2 Schedule: Lecture 1: Sample Testing: Preparation, conduct, documentation • Preparing the equipment • Setting specifications and acceptance criteria • Documentation of test results • Review and approval • Not to forget: Review of electronic audit trail Lecture 2: Handling out of specification (OOS) test results • Going through the FDA OOS guide • Learning from recent FDA warning letters • Going through an OOS checklist • Using out of trend (OOT) data to avoid OOS results • Documentation and follow-up: root cause, corrective action plan, preventive action plan Lecture 3: Quality assurance of reference standards and other supplies • Supplier qualification vs. sample testing • Selection and assessment of suppliers • Retesting of materials • Preparing working standards from reference standards • Correct labeling of chemicals Lecture 4: Training for GMP compliance • FDA requirements • identification of training needs • Developing a training plan • Making GMP training interesting • Documenting effectiveness of training Lecture 5: Ensuring Integrity of Raw Data and Other records • FDA Part 11 and EU-PIC/S Annex 11 requirements • Definition of Raw Data: Electronic vs. paper • Acquisition and recording of raw data • The importance of electronic audit trail • Archiving of electronic records for 'ready retrieval' Lecture 6: Internal audits in preparation for FDA inspection • Scheduling of audits • FDA Inspections as model for laboratory audits • Going through a typical FDA laboratory inspection • Responding to Typical inspectional/audit deviation • How to avoid FDA 483s and warning letters Lecture 7: Wrap up - Final questions and answers Speaker: Dr. Ludwig Huber Chief Advisor - Global FDA compliance, Agilent Technologies • Chairman, presenter and panel discussion member at US-FDA Industry Training sessions and conferences • Served as team member of PDA's task forces "21 CFR Part 11", of US-FDA internal documents, and of the GAMP® special interest group on Laboratory Systems. • Presenter of the Year of the Institute for Validation and Technology • Director and chief editor of, the global on-line resource for validation and compliance issues for laboratories. • Author of the books "Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems" Location: Mumbai, India Date: January 23rd and 24th, 2017 and Time: 9:00 AM to 6:00 PM Venue: The Leela Mumbai Address: Andheri Kurla Road, Sahar Village, Andheri-Kurla Road, Mumbai, Maharashtra 400059 Price: Register now and save ₹ 2000. (Early Bird) Until December 10, Early Bird Price: ₹ 14,000 from December 11 to January 21, Regular Price: ₹ 16,000 Registration Details: NetZealous - GlobalCompliancePanel NetZealous Services India Pvt. Ltd. Gururaya Mansion, 759 to 764, 8th Main road, J.P.Nagar, Bangalore - 560078 Karnataka, INDIA Phone: 1800 425 9409 Fax: 080-25149544 Registration Link - Follow us on LinkedIn:

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February 2017

2017 Pharma Market Research Conference USA

February 1-2, 2017

Hilton Parsippany Hotel, Parsippany, NJ, United States

The Pharma Market Research Conference offers an in-depth look at the future of pharmaceutical market research presented by internationally renowned speakers in first-class sessions. We bring together the top thought leaders in pharmaceutical, biotechnology, medical device, and diagnostics to create an environment of new ideas, connections and perspectives. Your VIP access includes valuable face time with other key decision makers, learning about the most crucial issues facing today’s market research community, and taking advantage of a world-class line up of speakers and panelists offering their unique insights and expertise on the topics you care about most. The Pharma Market Research Conference is widely attended by a large variety of professionals from large, medium-sized, and emerging pharmaceutical, biotechnology, medical device, and diagnostics companies. Market Research/Marketing Research Global Marketing/Marketing Brand Management/Product Management Strategic Planning/Business Planning Business Research Qualitative Research/Quantitative Research New Products/Product Planning and Analysis Business Intelligence/Competitive Intelligence Customer Insights Knowledge/Information Management Industrial Research/Information Customer-Scientific-Medical Research/Information Emarketing/eBusiness/eDetailing Business Development/Marketing and Sales

21st Annual ARC Industry Forum: Industry in Transition: Realizing the Digital Enterprise

February 6-9, 2017

Renaissance Orlando at SeaWorld, Orlando, FL, United States

How will disruptive technologies change existing products and plants? How will open source solutions impact traditional software and automation domains? Is digitalization a threat to cybersecurity and, if so, how can the risk be mitigated? How ‘smart’ are smart machines, and what benefit will these bring? How do Big Data and predictive and prescriptive analytics enable operational change? How do connected products create opportunities in aftermarket services? What software capabilities are needed to achieve transformational change? Which industries are already changing? What steps can organizations take to foster innovative thinking? Join us at the 21st annual ARC Industry Forum in Orlando, Florida to learn more about how the digital enterprise will be realized and the benefits that this can bring. Discover what your peers are doing today and what steps they are taking in their respective journeys.

2017 GPhA Annual Meeting

February 13-15, 2017

JW Marriott Orlando Grande Lakes, Orlando, FL, United States

Welcome to the GPhA 2017 Annual Meeting! Each year, nearly 700 attendees gather to gain insight on how the nation's most critical health and regulatory issues will impact the generic industry and the consumers who benefit from access to affordable medicines.

Our meeting attracts leading speakers from around the globe who will leave attendees with a comprehensive understanding of the opportunities and challenges for the generic pharmaceutical sector in 2017. This lineup – combined with unparalleled networking opportunities – makes GPhA's Annual Meeting the generic industry event of the year.

GPhA’s Annual Business Exposition offers a highly interactive and professional business environment in which industry vendors can meet generic industry executives. Building on the success of prior years, we offer our exhibitors abundant networking time with industry decision-makers by hosting breakfasts and breaks in the Expo ballroom as well as an Exhibit Hall Meet and Greet on Monday prior to the Welcome Reception. And the Tuesday afternoon GPhA Business Expo Reception has proven to be a highly profitable time for our exhibitors. Register Today!

Biologistics World Asia 2017

February 15-16, 2017

Singapore, Singapore, Non-U.S., Singapore

Biologistics World Asia will be the MOST Targeted event in Asia that focuses on cold- chain logistics for biomedical products. Bioplogistics World Asia 2017 will be attended by decision makers from regional and international biopharmaceuticals and biotechnology firms, top CMOs and CROs, government organizations and key global and Asian regulators. It’s your one stop solution to reach out to Asia’s logistics and supply chain industry!

Biologistics World Korea 2017

February 15-16, 2017

Seoul, Korea, Seoul, Non-U.S., Korea South

Biologistics World Korea is the MOST Targeted event in Korea that focuses on supply chain management and logistics for biologics and vaccines.The programme promises to bring together key opinion leaders, rising players and market experts to discuss, debate and brainstorm on the most pertinent issues affecting Korea’s logistics network within a global context!

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March 2017

Pittcon 2017

March 5-9, 2017

McCormick Place, Chicago, IL, United States

Pittcon 2017 will be held March 5-9, 2017, in Chicago, Illinois, at McCormick Place West. Pittcon offers a unique, once a year opportunity to get a hands-on look at product innovations from leading companies and to learn the latest techniques from world-renowned members of the scientific community. Find solutions to all your laboratory challenges.

eyeforpharma Barcelona 2017

March 14-16, 2017

CCIB, Barcelona, Non-U.S., Spain

15th Annual eyeforpharma Barcelona 2016 is Europe’s largest commercial pharma meeting of 1000+ industry leaders focused on commercial innovation, engagement strategy, patient centricity and stakeholder collaboration. 1000+ delegates, 80+ senior level speakers, 3 tracks: Speakers Include: Gregory Behar, CEO, Nestle Health Science Richard Francis, CEO, Sandoz David Ricks, President Lilly Bio Medicines, Lilly Why Barcelona? Collaborative setting: In 2017, our aim is to ensure your key stakeholders are present to advance partnerships with healthcare, technology, patients and patient associations An inspiring agenda: As you undergo a commercial evolution we will provide 3 targeted tracks, intimate workshops and stakeholder sessions to help direct your journey 1000+ in attendance: If you are looking for one commercial meeting to attend in 2017, Barcelona will be sure to give you the most senior networking opportunity possible For more information visit:

DCAT Week ‘17

March 20-23, 2017

New York City, NY, United States

DCAT Week is the premier business development event for companies engaged in and supporting pharmaceutical development and manufacturing. Its unique model brings together members for high-level strategic meetings with key decision makers, timely educational programs and important networking opportunities. It is organized by the Drug, Chemical & Associated Technologies Association (DCAT).


March 21-23, 2017

Javits Center, New York, NY, United States

At INTERPHEX, find all of the State-of-the-Art Solutions you need to Cost Effectively Develop and Manufacture Product. INTERPHEX is a premier pharmaceutical, biotechnology, and medical device development and manufacturing event and sponsored by Parenteral Drug Association (PDA). Dedicated to Innovation, Technologies and Knowledge, the show focuses on the entire product development life cycle. Held in New York City, it brings over 10,000 global industry professionals together with 600+ suppliers through a unique combination of our no cost technical conference, exhibits, demonstrations, workshops, partnering opportunities, and networking events. . INTERPHEX offers annual national and international industry events and educational opportunities around the world. Follow INTERPHEX on Facebook, LinkedIn, Instagram, YouTube, and Twitter. IPX Blog continues the learning beyond the show floor. For more information, visit

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April 2017

Bioprocessing and Manufacturing Conference 2017

April 10-12, 2017

The Grand Hyatt, Washington, DC, United States

With new vaccine formulations and technology platforms, vaccine developers need to have the right processes in place to manufacture them during clinical trials and at commercial scale. Use this opportunity to meet with the manufacture and bioprocessing leads who need services for all of the latest manufacturing challenges, from formulating and manufacturing adjuvants, mRNA platforms, VLPs and viral vectors, to technology transfer and continuous manufacturing. Bioprocessing and Manufacturing Conference 2017 is one of the 7 different conference streams at the 17th annual World Vaccine Congress Washington. By bringing seven events together under one roof, you get to choose the sessions which are the most applicable to help your business plan for the future of vaccine research, development and manufacture. Take just three days out of the office to meet over 600+ potential customers who need to find solutions to their challenges. For more information and to register, please visit

Influenza and Respiratory Vaccine Conference

April 10-12, 2017

The Grand Hyatt, 1000 H Street NW, 20001, Washington, DC, United States

This event will tackle the latest issues affecting vaccines for respiratory diseases including influenza, TB, RSV and MERS to stimulate the industry to develop more effective vaccines. Ensure you use this event to make people aware of your expertise around key topics such as universal and seasonal flu, maternal immunization and pandemic preparedness. Influenza and Respiratory Vaccine Conference is one of the 7 different conference streams at the 17th annual World Vaccine Congress Washington. By bringing seven events together under one roof, you get to choose the sessions which are the most applicable to help your business plan for the future of vaccine research, development and manufacture. Take just three days out of the office to meet over 600+ potential customers who need to find solutions to their challenges. For more information and to register, please visit

The International Liver Congress 2017

April 19-23, 2017

RAI Amsterdam, Amsterdam, Non-U.S., Netherlands

Anyone interested in hepatology, gastroenterology, internal medicine, cell biology, transplant surgery, infectious diseases, microbiology and virology, pharmacology, pathology and radiology and imaging should attend. Specialists share recent data, present studies, and findings, and discuss the hottest topics on liver disease. The annual Congress attracts in excess of 10,000 delegates and 250 media representatives from all over the world making this a truly international networking opportunity!

4th Annual Peptides Congress 2017

April 24-25, 2017

To be confirmed, London, Non-U.S., United Kingdom

Oxford Global Conferences are proud to announce the 4th Annual Peptides Congress, taking place on 24 – 25 April 2017 in London, UK. This highly anticipated conference provides a unique opportunity for over 400 senior-level delegates to engage in scientific discussions about the current research results and latest advancements that help the industry going forward.Over 25 presentations and case studies focusing on the key advancements in peptides technologies, chemistry, formulation & delivery as well as peptide therapeutics Two-day interactive conference addressing three main themes: - Recent Progress in Peptide Technologies & Manufacturing - Peptide Discovery & Development: Peptide Chemistry, Formulation & Delivery - Advances in Peptide Therapeutics Co-located with the 10th Annual Proteins & Antibodies Congress, the event will have 14 pre-scheduled one to one meetings, exhibition and informal networking opportunities The 2017 Peptides Congress features a revamped conference agenda that will focus on peptide technologies & manufacturing as well as peptide chemistry, formulation & delivery on Day 1. Stream 1 will feature presentations covering recent progress in peptide synthesis, advancements in peptide screening as well as updates in peptide stabilisation and efficient manufacturing of peptides. In Stream 2 our highly acknowledged speakers will focus on such hot topic areas as utilising macrocyclic peptides in drug discovery, novel strategies for peptide formulation and devices for the effective delivery of peptides. The areas of enhancing the immunogenicity of peptides as well as peptide analysis & quantification will also be addressed. Day 2 of the event will focus on peptide therapeutics. Novel case studies from exciting research areas such as diabetes, metabolic diseases and well as abdominal pain disorders will be covered. Renowned experts will also deliver talks on peptide drug conjugates, peptide-based vaccines and immunotherapies.

Advances in Companion Diagnostics Congress

April 25-26, 2017

TBC, London, Non-U.S., United Kingdom

Oxford Global Conferences are proud to present the Inaugural Advances in Companion Diagnostics Congress, taking place on the 25-26 April 2017 in London. Over two days our event will bring together 300 senior level attendees from academia, research institutes and pharma companies to discuss the current challenges and future perspectives of companion diagnostics. This event provides an ideal platform to participate in formal 1-1 meetings and informal networking drinks with other key industry figures, as well as providing opportunities to exchange ideas with some of the most influential professionals in the field. Companion diagnostics are laboratory tests and test kits used to determine the suitability of patients for tailored or targeted forms of therapy, e.g., therapies that act on unique biochemical pathways or that require specific genotypes or mutations. Diagnostics are used to assist in the identification of genetic mutations with implications regarding health and treatment decisions. Genetic testing has become an important piece of the continuously evolving health-care model. It is now possible to identify diseases before symptoms appear, predict the likelihood of disease development, and implement lifestyle or therapeutic interventions that will reduce or eliminate the effects of disease. Closer investigation into the nature of disease has sometimes revealed a more complex set of interactions than what was previously understood. While human DNA has similarities, there are also many individual differences. On day one our esteemed speakers will discuss the progress of diagnostic development in therapeutic areas. There will be a whole stream dedicated to exploring the opportunities and challenges of diagnostic development, including the regulatory issues surround the tests, and a number of clinical case studies with a focus on biomarkers, exosome markers and glycol-biology. Day one will also focus on the current issues surrounding imaging, with a wide range of talks focussing on different imaging technologies such as digital PCR and personalised molecular imaging. On day two the event will move more toward the advances in molecular diagnostics, with an analysis of how MDx is being applied to key areas such as auto-immune disease and oncology. We will also hear from experts discussing the use the liquid biopsy and the quest to make it more efficient. You will have the opportunity to hear from key figures as to how CDx is being used in new and exciting therapeutic areas such as primary care, rare disease and neuroscience. The conference will also focus on how CDx is being used in collaboration with NGS technologies. For more information please contact Danielle:

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May 2017

Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation): 2-Day Workshop

May 15-16, 2017

Venue to be announced shortly, Boston, MA, United States

Course Description: The Process Validation Guidelines (January 2011) and the EU Annex 15: Qualification and Validation (October 2015) outline the general principles and approaches the two regulatory bodies consider appropriate elements of process validation for the manufacture of human and animal drugs and biological products, including Active Pharmaceutical Ingredients (APIs). 
This two day, interactive Seminar which provides a conduit to enhance your understanding of the Continued Process Verification, will be reviewed in detail: where does it begin; what is included; and, when does it end. Common questions asked by the users of Process Validation include; How does one integrate these two different concepts (Phase 1, 2, and 3 vs. Stages 1, 2, and 3) and where do they merge? Do they exist independently of each other or do they complement each other to enhance, build and provide a product that neither alone could. Questions that may arise include where are cGMPs initiated? To what extent must they be used? Since Stage 3 extends through commercial batch manufacturing, what happens to Phase 3? Does it follow along or with Stage 3? Questions that exist include how one manages special situations to include viral inactivation and removal, impurity clearance, process consistency, process solution stability, endotoxin, bioburden, and other miscellaneous cell culture tests to include DNA and host cell protein. These questions will be addressed within Stage 2 as presented here and include utilization of Process Validation and Phase 1, 2 and 3, where their Guidances blend and where they remain distinct. In particular, Stage 3. Important: Please plan to bring a multidisciplinary group from your Company to gain the most from this very important seminar.

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June 2017

13th European Congress of Clinical Pharmacology and Therapeutics - EACPT 2017

June 24-27, 2017

CLARION CONGRESS HOTEL PRAGUE, Freyova 33 - 190 00, Prague, Non-U.S., Czech Republic

The main focus of EACPT 2017 is the role of clinical pharmacology in personalized pharmacotherapy, both a priori – pharmacogenetics – and a posteriori (therapeutic drug monitoring). The topic list includes a broad spectrum of topics that relate to Clinical Pharmacology: - Access to medicines. Innovation and sustainability of National Health Systems - Cardiovascular pharmacology and diabetes - Clinical toxicology - Clinical trials methodology - Drug development and regulatory sciences - Drug Safety and pharmacovigilance - Education - Global Health - Research Ethics - Pharmacoeconomics and health technology assessments - Inflammatory and immune based diseases and treatments - Infectious diseases. Antibiotics, antivirals, antifungals. - Neuro-psychopharmacology - Oncology - Orphan medicines - Research using Electronic Health Records. - Pharmacology of pain - Pharmacogenetics and pharmacogenomics - Pharmacokinetics, TDM, PK-PD modelling and drug interactions - Special populations

DCAT Sharp Sourcing 2017

June 27-27, 2017

Hyatt Regency Hotel, New Brunswick, NJ, United States

DCAT Sharp Sourcing 2017 is a conference and networking event that provides peer and customer insight on the best practices and practical ways for optimizing pharmaceutical manufacturing and supply networks. The event is designed for senior to mid-level executives engaged in sourcing, procurement, supply management, and external manufacturing and their business counterparts on the supply side. It is organized by the Drug, Chemical & Associated Technologies Association (DCAT).

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November 2017

South African Pharmaceutical Exhibition (SAPHEX)

November 28-29, 2017

Sandton Convention Centre, 161 Maude Street, Sandton, Non-U.S., South Africa

Saphex is rapidly establishing itself as the most strategic industry event in the South African region that brings together all major stakeholders – industry leaders, policy-makers, regulators, academics, investors, scientists and patient representatives, to tackle the most pressing issues the industry is facing. With over 2000 visitors expected at Saphex 2017, there will be ample opportunity for you to connect and establish relationships with fellow professionals from the pharmaceutical industry. We are also anticipating over 130 exhibitors and over 100 countries represented at the event. The event will incorporate an exhibition and a conference, delivering business contacts and forging strategic alliances in combination with the knowledge and information that you will need to win in the South African pharmaceutical sector. Saphex will be held under the theme, 'Continuing development of the South African Pharmaceutical Industry: Forging ideas for the future composition of the sector'. Aiming to explore the current composition of the industry in South Africa, and inviting several experts in their respective fields to give their opinion on where the future of the market may lead. The approach that companies pursue will hinge upon their individual goals. Inevitably companies will need to decide how to satisfy contending stakeholder demands while pursuing sustainable growth in a competitive market.

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