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July 2016

Seminar on Complaint Handling and Management: From Receipt to Trending

July 25-26, 2016

WILL BE ANNOUNCED SOON , Copenhagen, Denmark , CA, Denmark

Course "Complaint Handling and Management: From Receipt to Trending" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken. The results of this evaluation should lead to a conclusion regarding whether the complaint was valid, what the root cause of the complaint was, and what action is necessary to prevent further occurrences. Complaints cannot be ignored. They are an excellent indicator of problems with the use, design, and/or manufacture of a product. A single complaint that is thoroughly investigated may lead a company to take remedial or corrective action. It may also take an ongoing analysis of numerous complaints before a trend is spotted that causes a company to initiate changes in their product, labeling, packaging or distribution. The regulatory expectations for both pharmaceuticals and medical devices will be emphasized as well as overview of best practices for timely and effective investigations. Trending is the only way a company can stay on top of emerging quality issues and address those that are most pressing. Medical Device Reporting (MDR) is the mechanism for FDA to receive significant medical device adverse events from manufacturers, importers and user facilities, so they can be detected and corrected quickly. User Facilities (e.g., hospitals, nursing homes) are required to report suspected medical device related deaths to both the FDA and the manufacturers. User facilities report medical device related serious injuries only to the manufacturer. If the medical device manufacturer is unknown, the serious injury is reported by the facility to FDA. Health professionals within a user-facility should familiarize themselves with their institution procedures for reporting adverse events to the FDA. The MDR process impacts device user facilities, manufacturers, importers, and distributors. If you are a device user facility, you must report deaths and serious injuries that a device has or may have caused or contributed to, establish and maintain adverse event files, and submit summary annual reports. If you are a manufacturer or importer, you must report deaths and serious injuries that your device has or may have caused or contributed to, you must report certain device malfunctions, and you must establish and maintain adverse event files. If you are a manufacturer, you must also submit specified follow-up. Recall means the correction or removal of a device for human use where FDA finds that there is a reasonable probability that the device would cause serious, adverse health consequences or death. It is an action taken to address a problem with a medical device that violates FDA law. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health. A medical device recall does not always mean that you must stop using the product or return it to the company. A recall sometimes means that the medical device needs to be checked, adjusted, or fixed. If an implanted device (for example, a pacemaker or an artificial hip) is recalled, it does not always have to be removed. When an implanted device has the potential to fail unexpectedly, companies often tell doctors to contact their patients to discuss the risk of removing the device compared to the risk of leaving it in place. FDA classifies medical device recalls into three categories, representing the potential risk to public health: Class I, II, and III. Why should you attend: • Understand that although FDA does not specify a standard complaint handling system, the requirements do specify certain actions that shall be included in any system • Grasp and comprehend the definitions and elements of the regulatory requirements for Complaint Handling, Medical Device Reporting and handling of Recalls • All personnel who deal with customers, or who may receive a complaint call, must be trained in the proper routing/handling of complaints • Provide information about FDA's Medical Device Reporting MDR) regulation and the Voluntary Reporting program called MedWatch • Introduce you Medical Device Reporting and to help you better understand the process and benefits of Voluntary Reporting and responsibilities • Latest Amendments to the MDR Regulation to Implement FDAMA Changes • To Recall or Not to Recall: Issues to consider regarding whether a Field Action is required • Determine when a recall is required and how to manage a recall, who must report, when to report, what to report, where to report, recordkeeping requirements, FDA regulatory authority, references and guidance • Seminar attendees are encouraged to bring examples of their work from the functional area on the various topics as applicable for group discussion • Review and discuss pain points,challenges and solutions Areas Covered in the Session: Areas of special concentration will include: • Reporting complaints • Managers • Complaint evaluation and investigation • Data collection and trending • CAPA process for investigating complaints • Accelerate complaints recording, investigation, reporting, escalation/triggers and closure cycle as cases are automatically routed from one stage to the next • Gain enterprise-wide visibility into the complaints data and track the process with performance metrics, dashboards or other indicators • Improve communication and teamwork on complaints across departments and functional areas • Drive continuous improvement by tying corrective actions with complaints for a closed loop quality process • Improve management of the complaint lifecycle with real-time trending and escalation of customer complaints • Understand the History of MDR Regulation • What types of Reports does the FDA receive and who must submit Mandatory Reports to the FDA? • Who can submit Voluntary Reports to the FDA? • How Does the FDA Use Medical Device Reports? • What are the exemptions, variances, or alternative forms of adverse event reporting requirements? • Basics of a Recall: Initiation, Classification and Public Warning • Medical Device Recall Reporting • Recall Responsibilities & Requirements • FDA's Role • Introduction to Medical Device Recalls: Industry Responsibilities • Recall Communication and Strategy • Monitoring and Auditing Recall Effectiveness • Recall Termination • Guidance for Industry, Trends and FDA Inspection & Enforcement Statistics and Trends Who will benefit: • Regulatory management • QA management • Customer Service personnel • Sales personnel • Consultants • Quality system auditors Agenda: Day 1 Schedule Lecture 1: Complaint Handling: • What are the elements of an effective complaint management system? • How does risk management influence complaint handling decisions? • What are the responsibilities of other departments? • What is the best way to train customer contact employees? • What steps would the FDA expect to see the departments taking that sorts out potential MDRs, product complaints and other reportable events? • What and how do you perform trending? • What are examples of how companies trend and analyze service calls and product complaints? • Understand how and why CAPA is tied in to product complaint investigation • What is an appropriate complaint handling system in a risk-based post-market environment? • How do you audit a complaint handling system? • From your audits, how do you judge that your complaint handling system is effective? • Assignment of responsibility • Manufacturer should develop a method for maintaining records of complaints and investigations that: is functional and economical, meets company needs, and meets FDA requirements and expectations • Identify designated complaint handling unit • Instructions for documenting complaint information • Process for evaluating complaints • Process for investigating complaints • Identify and process MDR's • How to process customer returns • Records and trend analysis • Complaint closure • Examples of tools currently being used to conduct investigations • How far and in-depth do you go with your investigations • What are current FDA "hot" buttons and trends, benchmarks and best practices for investigations • How to become a "good" investigator and the emphasis on closed-loop investigations • Written Procedures: Designated Complaint Handling Unit, Training and Records • Recent Enforcement Actions Lecture 2: Medical Device Reporting • Introduction to Medical Device Reporting • What are the key terms, definitions and forms? • MDR procedures and processes • What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me? • How do you manage international reporting requirements under your complaint handling system? • Consider the relationship between MDRs and Risk Assessments Lecture 3: Exercise and Recap of Day 1 • Exercise on Product Complaints/Complaint Handling • Quiz Day 2 Schedule Lecture 1: Medical Device Reporting • eMDR Electronic Medical Device Reporting • How to Report a Problem • Event Problem Codes and Manufacturer Evaluation Codes • MedWatch: Safety Information and AER Program • Completing Form FDA 3500A • What form should I use to submit reports of individual adverse events and where do I obtain these forms? • Where and how do I submit reports and additional information? • Does the information in my report constitute an admission that the device caused or contributed to the reportable event? • What are the requirements for developing, maintaining, and implementing written MDR procedures and maintain records/files that apply to me? • Requirements for Individual Adverse Event Reports • User Facility Reporting, Importer Reporting and Manufacturer Reporting Requirements Lecture 2: Recalls • What happens in a medical device recall: Firm-initiated recall vs. mandatory recall • What information needs to be reported? • What types of records do companies need to keep? • Prior to notifying FDA, what steps should you have taken? • What are the dos and don'ts when informing FDA of a product problem? • Who should be involved in the decision process? • Who should be responsible for communicating with FDA? • What are the consequences of a recall? • What factors should you consider when determining whether or not to get your product back? • How do you prepare for a post recall inspection? • What customer and other outside communications are necessary? • What documentation should be prepared? • How should the product liability implications of recall communications be handled? • What is an effectiveness check? • Health Hazard Evaluations are conducted by FDA • How should you write your recall correspondence? • How do you determine that your recall is completed and what do you do to close your recall internally and with FDA? • Create and use a recall operational • Understand what is required for the recall strategy as expected by FDA • Depth of recall and using a viable, sustainable and effective strategy • Understand why the documentation and paper trail are so critical and termination of a recall • Discuss most recent recalls not only for devices but pharmaceuticals and why the numbers are alarming Lecture 3: Exercise and Recap of Day 2 • Exercise - MDR and Recall • Quiz Speaker: David R Dills Regulatory Affairs & Compliance Consultant, David R. Dills, Regulatory & Compliance Consultant with more than 24 years of hands-on experience and a proven track record within the FDA regulated industry, has an extensive regulatory and compliance background with Class I/II/III and IVD devices, pharmaceutical operations, and manages activities within the global regulatory and compliance space. Location: Copenhagen, Denmark Date: July 25th and 26th, 2016 and Time: 9:00 AM to 6:00 PM Venue: WILL BE ANNOUNCED SOON Price: Register now and save $200. (Early Bird) Price: $1,695.00 (Seminar Fee for One Delegate – Without stay) Until June 20, Early Bird Price: $1,695.00 from June 21 to July 23, Regular Price: $1,895.00 Price: $2,095.00 (Seminar Fee for One Delegate – With stay) Until June 20, Early Bird Price: $2,095.00 from June 21 to July 23, Regular Price: $2,295.00 Quick Contact: NetZealous DBA as GlobalCompliancePanel Phone: 1-800-447-9407 Fax: 302-288-6884 Email: support@globalcompliancepanel.com Website: http://www.globalcompliancepanel.com Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900551SEMINAR Follow on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel


Cape Town Seminar on Complaint Handling and Management

July 25-26, 2016

WILL BE ANNOUNCED SOON, Cape Town, SA, Non-U.S., South Africa

Course "Complaint Handling and Management: From Receipt to Trending" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken. The results of this evaluation should lead to a conclusion regarding whether the complaint was valid, what the root cause of the complaint was, and what action is necessary to prevent further occurrences. Complaints cannot be ignored. They are an excellent indicator of problems with the use, design, and/or manufacture of a product. A single complaint that is thoroughly investigated may lead a company to take remedial or corrective action. It may also take an ongoing analysis of numerous complaints before a trend is spotted that causes a company to initiate changes in their product, labeling, packaging or distribution. The regulatory expectations for both pharmaceuticals and medical devices will be emphasized as well as overview of best practices for timely and effective investigations. Trending is the only way a company can stay on top of emerging quality issues and address those that are most pressing. Medical Device Reporting (MDR) is the mechanism for FDA to receive significant medical device adverse events from manufacturers, importers and user facilities, so they can be detected and corrected quickly. User Facilities (e.g., hospitals, nursing homes) are required to report suspected medical device related deaths to both the FDA and the manufacturers. User facilities report medical device related serious injuries only to the manufacturer. If the medical device manufacturer is unknown, the serious injury is reported by the facility to FDA. Health professionals within a user-facility should familiarize themselves with their institution procedures for reporting adverse events to the FDA. The MDR process impacts device user facilities, manufacturers, importers, and distributors. If you are a device user facility, you must report deaths and serious injuries that a device has or may have caused or contributed to, establish and maintain adverse event files, and submit summary annual reports. If you are a manufacturer or importer, you must report deaths and serious injuries that your device has or may have caused or contributed to, you must report certain device malfunctions, and you must establish and maintain adverse event files. If you are a manufacturer, you must also submit specified follow-up. Recall means the correction or removal of a device for human use where FDA finds that there is a reasonable probability that the device would cause serious, adverse health consequences or death. It is an action taken to address a problem with a medical device that violates FDA law. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health. A medical device recall does not always mean that you must stop using the product or return it to the company. A recall sometimes means that the medical device needs to be checked, adjusted, or fixed. If an implanted device (for example, a pacemaker or an artificial hip) is recalled, it does not always have to be removed. When an implanted device has the potential to fail unexpectedly, companies often tell doctors to contact their patients to discuss the risk of removing the device compared to the risk of leaving it in place. FDA classifies medical device recalls into three categories, representing the potential risk to public health: Class I, II, and III. Why should you attend: • Understand that although FDA does not specify a standard complaint handling system, the requirements do specify certain actions that shall be included in any system • Grasp and comprehend the definitions and elements of the regulatory requirements for Complaint Handling, Medical Device Reporting and handling of Recalls • All personnel who deal with customers, or who may receive a complaint call, must be trained in the proper routing/handling of complaints • Provide information about FDA's Medical Device Reporting MDR) regulation and the Voluntary Reporting program called MedWatch • Introduce you Medical Device Reporting and to help you better understand the process and benefits of Voluntary Reporting and responsibilities • Latest Amendments to the MDR Regulation to Implement FDAMA Changes • To Recall or Not to Recall: Issues to consider regarding whether a Field Action is required • Determine when a recall is required and how to manage a recall, who must report, when to report, what to report, where to report, recordkeeping requirements, FDA regulatory authority, references and guidance • Seminar attendees are encouraged to bring examples of their work from the functional area on the various topics as applicable for group discussion • Review and discuss pain points,challenges and solutions Areas Covered in the Session: Areas of special concentration will include: • Reporting complaints • Managers • Complaint evaluation and investigation • Data collection and trending • CAPA process for investigating complaints • Accelerate complaints recording, investigation, reporting, escalation/triggers and closure cycle as cases are automatically routed from one stage to the next • Gain enterprise-wide visibility into the complaints data and track the process with performance metrics, dashboards or other indicators • Improve communication and teamwork on complaints across departments and functional areas • Drive continuous improvement by tying corrective actions with complaints for a closed loop quality process • Improve management of the complaint lifecycle with real-time trending and escalation of customer complaints • Understand the History of MDR Regulation • What types of Reports does the FDA receive and who must submit Mandatory Reports to the FDA? • Who can submit Voluntary Reports to the FDA? • How Does the FDA Use Medical Device Reports? • What are the exemptions, variances, or alternative forms of adverse event reporting requirements? • Basics of a Recall: Initiation, Classification and Public Warning • Medical Device Recall Reporting • Recall Responsibilities & Requirements • FDA's Role • Introduction to Medical Device Recalls: Industry Responsibilities • Recall Communication and Strategy • Monitoring and Auditing Recall Effectiveness • Recall Termination • Guidance for Industry, Trends and FDA Inspection & Enforcement Statistics and Trends Who will benefit: • Regulatory management • QA management • Customer Service personnel • Sales personnel • Consultants • Quality system auditors Agenda: Day 1 Schedule Lecture 1: Complaint Handling: • What are the elements of an effective complaint management system? • How does risk management influence complaint handling decisions? • What are the responsibilities of other departments? • What is the best way to train customer contact employees? • What steps would the FDA expect to see the departments taking that sorts out potential MDRs, product complaints and other reportable events? • What and how do you perform trending? • What are examples of how companies trend and analyze service calls and product complaints? • Understand how and why CAPA is tied in to product complaint investigation • What is an appropriate complaint handling system in a risk-based post-market environment? • How do you audit a complaint handling system? • From your audits, how do you judge that your complaint handling system is effective? • Assignment of responsibility • Manufacturer should develop a method for maintaining records of complaints and investigations that: is functional and economical, meets company needs, and meets FDA requirements and expectations • Identify designated complaint handling unit • Instructions for documenting complaint information • Process for evaluating complaints • Process for investigating complaints • Identify and process MDR's • How to process customer returns • Records and trend analysis • Complaint closure • Examples of tools currently being used to conduct investigations • How far and in-depth do you go with your investigations • What are current FDA "hot" buttons and trends, benchmarks and best practices for investigations • How to become a "good" investigator and the emphasis on closed-loop investigations • Written Procedures: Designated Complaint Handling Unit, Training and Records • Recent Enforcement Actions Lecture 2: Medical Device Reporting • Introduction to Medical Device Reporting • What are the key terms, definitions and forms? • MDR procedures and processes • What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me? • How do you manage international reporting requirements under your complaint handling system? • Consider the relationship between MDRs and Risk Assessments Lecture 3: Exercise and Recap of Day 1 • Exercise on Product Complaints/Complaint Handling • Quiz Day 2 Schedule Lecture 1: Medical Device Reporting • eMDR Electronic Medical Device Reporting • How to Report a Problem • Event Problem Codes and Manufacturer Evaluation Codes • MedWatch: Safety Information and AER Program • Completing Form FDA 3500A • What form should I use to submit reports of individual adverse events and where do I obtain these forms? • Where and how do I submit reports and additional information? • Does the information in my report constitute an admission that the device caused or contributed to the reportable event? • What are the requirements for developing, maintaining, and implementing written MDR procedures and maintain records/files that apply to me? • Requirements for Individual Adverse Event Reports • User Facility Reporting, Importer Reporting and Manufacturer Reporting Requirements Lecture 2: Recalls • What happens in a medical device recall: Firm-initiated recall vs. mandatory recall • What information needs to be reported? • What types of records do companies need to keep? • Prior to notifying FDA, what steps should you have taken? • What are the dos and don'ts when informing FDA of a product problem? • Who should be involved in the decision process? • Who should be responsible for communicating with FDA? • What are the consequences of a recall? • What factors should you consider when determining whether or not to get your product back? • How do you prepare for a post recall inspection? • What customer and other outside communications are necessary? • What documentation should be prepared? • How should the product liability implications of recall communications be handled? • What is an effectiveness check? • Health Hazard Evaluations are conducted by FDA • How should you write your recall correspondence? • How do you determine that your recall is completed and what do you do to close your recall internally and with FDA? • Create and use a recall operational • Understand what is required for the recall strategy as expected by FDA • Depth of recall and using a viable, sustainable and effective strategy • Understand why the documentation and paper trail are so critical and termination of a recall • Discuss most recent recalls not only for devices but pharmaceuticals and why the numbers are alarming Lecture 3: Exercise and Recap of Day 2 • Exercise - MDR and Recall • Quiz Speaker: David R Dills Regulatory Affairs & Compliance Consultant, David R. Dills, Regulatory & Compliance Consultant with more than 24 years of hands-on experience and a proven track record within the FDA regulated industry, has an extensive regulatory and compliance background with Class I/II/III and IVD devices, pharmaceutical operations, and manages activities within the global regulatory and compliance space. Location: Cape Town, SA Date: July 25th and 26th, 2016 and Time: 9:00 AM to 6:00 PM Venue: WILL BE ANNOUNCED SOON Price: Register now and save $200. (Early Bird) Price: $1,695.00 (Seminar Fee for One Delegate – Without stay) Until June 20, Early Bird Price: $1,695.00 from June 21 to July 23, Regular Price: $1,895.00 Price: $2,095.00 (Seminar Fee for One Delegate – With stay) Until June 20, Early Bird Price: $2,095.00 from June 21 to July 23, Regular Price: $2,295.00 Register for 5 attendees (With stay) Includes Price: $7,333.00 You Save: $3,142.5 (30%)* Until June 20, Early Bird Price: $1, 0475.00 from June 21 to July 23, Regular Price: $1, 0675.00 Quick Contact: NetZealous DBA as GlobalCompliancePanel Phone: 1-800-447-9407 Fax: 302-288-6884 Email: support@globalcompliancepanel.com Website: http://www.globalcompliancepanel.com Registration Link - http://bit.ly/1TX9GKm-complaint-handling Follow on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel


Advanced API 2016

July 25-27, 2016

The Westin, Mumbai, Mumbai, Non-U.S., India

The 3rd Annual Advanced API Convention will be held in Mumbai between 25 – 27 July 2016. Intended as the foremost event for the API industry in India, the Advanced API Convention 2016 is an exciting event bringing the scientists of the world, Industry experts and key stakeholders under one platform. The Indian API market stands third in the world. At the same time, it relies heavily on China. This is a serious matter of concern which needs to be addressed to reduce dependency on China. CPhI always strives to voice out the concerns of Pharma professionals, and this year again we are delighted to bring you the 3rd Annual Advanced API Convention with an idea to encourage production of quality API’s, tackling problems right from R&D to Manufacturing phase.


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August 2016

6th Digital Marketing for Medical Devices

August 1-3, 2016

Hyatt Regency Minneapolis, Minneapolis, MN, United States

Now in our sixth year, the Digital Marketing for Medical Devices event has become the place for device marketers to inspire and learn from one another. Return to the office with a strategy to provide your customers with engaging, relevant, valuable information via the channels they prefer. Join more than 150 device marketers at the leading marketing event for the medical device industry, where you’ll gain an in-depth understanding of how to develop an effective digital marketing campaign to increase your product and brand’s digital presence. Much like the industry is continuously changing, our programs have evolved to ensure you walk away from our conferences with new trends on your radar and a strategic plan to implement tactics that will improve your marketing.


Manufacturing and Marketing OTC Drugs in Compliance with FDA Regulations

August 2-3, 2016

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

Learn FDA regulatory requirements for manufacturing, labeling and marketing of cosmeceutical and homeopathic OTCs not covered by approved New Drug Applications. Learn OTC monographs and get tips to minimize the regulatory risk of Warning Letters and other FDA enforcement actions.


11th Annual Manufacturing Execution Systems(MES) 2016

August 10-11, 2016

Doubletree Center City, Philadelphia, PA, United States

MES 2016, the life science industry’s most in-depth manufacturing systems-focused event, is packed with breakthrough content and next-generation strategies for achieving the highest ROI on your MES activities. Gain insight on innovative applications and processes to master advanced IT-based solutions in highly regulated environments. Collaborate on prevailing industry approaches to ensure manufacturing intelligence and excellence by successfully deploying, integrating, maintaining and utilizing data from MES.


Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation)

August 18-19, 2016

Venue to be announced shortly, Burlingame, CA, United States

Attend this workshop to learn goals and objectives of Process Validation for pharma industry.


Statistical Analysis for Process and Product Development

August 25-26, 2016

Venue to be announced shortly, Tampa, FL, United States

Learn to apply Hypothesis Testing methods, use of confidence intervals, sample studies and Design of Experiments (DOE). You will learn Statistical Analysis for Process and Product Development through graphical analysis, experimental design, factorial design, significant effects and mathematical methods.


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.


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September 2016

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.


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.


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


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.


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.


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.


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 www.sensorsmidwest.com 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.


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October 2016

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.


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.


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.


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


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 - http://goo.gl/o1cZqz


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 - http://goo.gl/mZXSGU


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.


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 http://www.orphandrugs-event.com/evvnt 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


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.


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.


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 d.dalby@oxfordglobal.co.uk.


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)


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.


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


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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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.


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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: http://goo.gl/2929t3 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: http://goo.gl/2929t3


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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 http://goo.gl/Wsi2bO


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 http://goo.gl/GirnRV


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!


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: d.dalby@oxfordglobal.co.uk


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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


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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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