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May 2016

Pharmaceutical Traceability Forum

May 23-25, 2016

Sheraton Downtown Hotel, Philadelphia, PA, United States

–Harmonize serialization plans to achieve compliance. Supply chain stakeholders must take a comprehensive view of their traceability strategy to remain ahead of approaching deadlines. Designed to address the diverse challenges, the Pharmaceutical Traceability Forum is a peer-to-peer exchange on achieving global serialization. Gain an in-depth perspective on the ever-changing international deadlines, data interoperability, and explore cutting-edge pilot programs in our dynamic workshops. Hear 25+ speakers with new innovated programs put in place by top companies in our unique case studies and sector-specific round tables. The Pharmaceutical Traceability Forum this May 23-25 in Philadelphia is the industry’s premier event for pharmaceutical delivery and traceability experts to discuss how the development and compliance associated with serialization can be improved to foster efficiency and achieve patient safety.


Webinar - Mitigate the Risk of Receiving FDA 483 Observations, Leading to Warning Letters – Your Guide to a Preventative Approach

May 24-24, 2016

Online, Toronto, Ontaria, Canada

Why Attend this Webinar: - Hear common inspection observations from the FDA and key reasons for Form 483 and warning letters - Learn how best to handle FDA warnings with the appropriate corrective response Understand how Manufacturing Execution Systems (MES) can work as a preventative approach - Gain tips and techniques to improve manufacturing performance by over 25% - Access a live Q&A with a panel of FDA and MES experts


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June 2016

5th ANNUAL INNOPACK PHARMA CONFEX

June 2-3, 2016

Sahara Star Hotel, Mumbai, Non-U.S., India

InnoPack is a global brand of CPhI Worldwide - the "must attend" event in the International Pharmaceutical Industry. InnoPack brings together buyers and suppliers from the packaging and pharmaceutical industries, creating business opportunities through a dedicated worldwide forum. Into its 5th year, InnoPack Pharma has established itself as the premiere platform for Pharma Packaging Innovations. The show gathers pharma industry professionals over 2 days with attendees from 100+ companies who come to do business, exchange ideas, learn and form future alliances, and shape the future ofthe pharma packaging industry under one roof. Conference day one is dedicated to presentations and panel discussions for in-depth learning and knowledge sharing, covering the key aspects like regulations, global trends, serialisation and sustainability. While, day two focuses on changing technology, labelling, printing and aseptic packaging. SOME BRIEF FACTS: Delegates from over 80 companies attend InnoPack creating a unique environment where delegates can meet, learn and share ideas with each other Every year, over 79% of attendees find the products or services they were looking for 80% of the delegates who attend the confex have purchasing power or influence over buying


5th ANNUAL INNOPACK PHARMA CONFEX

June 2-3, 2016

Sahara Star Hotel, Mumbai, Non-U.S., India

InnoPack is a global brand of CPhI Worldwide - the "must attend" event in the International Pharmaceutical Industry. InnoPack brings together buyers and suppliers from the packaging and pharmaceutical industries, creating business opportunities through a dedicated worldwide forum. Into its 5th year, InnoPack Pharma has established itself as the premiere platform for Pharma Packaging Innovations. The show gathers pharma industry professionals over 2 days with attendees from 100+ companies who come to do business, exchange ideas, learn and form future alliances, and shape the future ofthe pharma packaging industry under one roof. Conference day one is dedicated to presentations and panel discussions for in-depth learning and knowledge sharing, covering the key aspects like regulations, global trends, serialisation and sustainability. While, day two focuses on changing technology, labelling, printing and aseptic packaging. SOME BRIEF FACTS: Delegates from over 80 companies attend InnoPack creating a unique environment where delegates can meet, learn and share ideas with each other Every year, over 79% of attendees find the products or services they were looking for 80% of the delegates who attend the confex have purchasing power or influence over buying


Microbiology Week 2016

June 7-9, 2016

Doubletree by Hilton Centery City, Philadelphia, PA, United States

IVT’s 4th Annual Microbiology Week offers attendees a two and a half day interactive, customizable and hands-on forum. The conference covers a wide variety of topics, ranging from the application of new and alternative rapid microbial identification technology, to the steps needed to ensure successful outcomes in FDA audits. Microbiology Week features the latest updates from industry leaders on new USP and FDA guidelines, especially as they relate to environmental monitoring, as well as strategies and solutions for everyday microbial practices that do not yet have standardized guidelines.


2016 PDA Biosimilars Conference

June 20-21, 2016

Hilton Baltimore, Baltimore, MD, United States

The 2016 PDA Biosimilars Conference will bring together all levels of industry professionals to network and benefit from a program that will provide an update on recent regulatory expectations for the approval of biosimilars. Industry experts and regulators will review and discuss new development strategies for biosimilars. Successful case studies will be presented to illustrate how analytical similarity can be demonstrated and practical control strategies (process validation and specifications) can be developed. Attendees will receive current updates from the regulatory agencies about which CMC aspects have been most challenging for the CMC reviewer, and they will have the opportunity to raise questions and concerns with these regulatory experts.


Conference on why FDA at my Facility is, and what do I do During an Inspection

June 21 - July 22, 2016

WILL BE ANNOUNCED SOON , Zurich, Switzerland , CA, Switzerland

Course "Why is FDA at my Facility, and What do I do During an Inspection" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Many regulated companies preparing for FDA inspections are not prepared and the outcome can be negative as we see all the time with enforcement actions. This seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no matter if you are a Class I, II, III device or a pharmaceutical or biologics manufacturer. This presentation will review and emphasize the do's and don'ts and cardinal rules as to interviewing, how to respond, reviewing documentation, etiquette, use of certain words, body language, responding to questions/requests, etc., and certainly replying to 483's and Warning Letters. Emphasis is placed on the company's SOP on dealing with inspectors and knowing how to be prepared, proactive...and being able to defend and justify... and what it takes to achieve a favorable outcome. This seminar provides background and understanding of the role played by the Agency, its administrative and enforcement powers. It takes the participant step by step through the entire inspection process and describes various types of inspections. Who will benefit: Industries • FDA regulated Industries o Medical Device o Pharmaceuticals o Clinical • Dietary Supplements o Food o Nutraceutical • Healthcare IT o Technical Services o Validation o Engineering Departments • Top and Middle Management • Quality Assurance/Management • Compliance Management • Manufacturing • Laboratory • Regulatory Affairs • Information Technology • Marketing & Sales • Operations • Research & Development Types of facilities: • Manufacturing facilities • Contract manufacturing facilities • Distributors • Packaging, Labeling • API Suppliers • Laboratories • Importers • Documentation Management Agenda: Day 1 Schedule Lecture 1: How a firm should prepare for an FDA inspection Lecture 2: Ways to train employees in view of the inspection Lecture 3: How to ensure that required documentation is in place Lecture 4: How to interact with the investigator-DO's and DON'T's Lecture 5: What companies should do when the inspection ends Lecture 6: How to reply to 483's and warning letters Lecture 7: Legal implications of non-compliance Lecture 8: Post inspection actions Day 2 Schedule Lecture 1: Why inspections are conducted and by what statutory authority Lecture 2: The emphasis on systems-based inspections...and the IOM and other crucial FDA reference documents Lecture 3: What is subject to FDA purview and what's off-limits Lecture 4: Understand and apply the do's and don'ts and comprehend that preparation is the key to success Lecture 5: What are the prohibited "Acts" and the enforcement categories that you need to deal with Lecture 6: What you need to know and do to prepare for, during and even after the inspection...and why your inspection response team is key Lecture 7: The company's Inspection Plan (SOP) can make or break the inspection depending on how to use it and training your personnel Lecture 8: How to respond to findings and facilitating the documentation and remediation process...and reaching final closure Lecture 9: Define clear responsibilities, roles and goals for personnel involved in SOP development 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. He manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations and commercial opportunities and develops strategies for governmental approval to introduce new products to market, provides guidance on regulatory and compliance requirements and prepares/reviews worldwide submissions/dossiers/technical files and addresses global regulatory requirements. Location: Zurich, Switzerland Date: July 21st and 22nd, 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 19, 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 19, 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=900549SEMINAR Follow on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel


Sensors Expo & Conference

June 22-23, 2016

McEnery Convention Center, San Jose, CA, United States

Pre-Conference Symposia: June 21, 2016

Sensing Technologies Driving Tomorrow’s Solutions

Sensors Expo & Conference is the only industry event in North America exclusively focused on sensors and sensor-integrated systems. For over 30 years, Sensors has brought technical innovation and thought leadership to engineers involved in the development and deployment of sensors and sensing systems. The 3-day program explores cutting-edge trends and applications including Energy Harvesting, Flexibles & Wearables, IoT, Measurement & Detection, MEMS & Sensors, Novel Sensor Applications, Optics, Sensors & Embedded Systems Design, and Wireless in an information-packed Conference Program and reflects those trends throughout the Exhibit Floor with new products, technology pavilions, demos, and a showcase of 250+ of the latest sensors on display.

Join us at the industry’s premier gathering of engineers to find the solutions for your present challenges while exploring sensing technologies that are driving tomorrow’s solutions.

Special offer for subscribers to attend Sensors 2016: Use code PHARMA50 for $50 off Gold & Main Conference Passes or a FREE Expo Hall Pass in advance. Visit www.sensorsexpo.com to register today and for the latest information on the 2016 event.


CLEANING VALIDATION WORKSHOP 2016

June 23-24, 2016

HILTON MUMBAI INTERNATIONAL AIRPORT, Mumbai, Non-U.S., India

With the increase in scrutiny by US FDA, the Indian Pharmaceutical Industry is striving to comply with the cGMP guidelines. In order to ensure failure free compliance, it is a must for the pharmaceutical manufacturers to validate its cleaning processes to avoid cross contamination and ensure safety and efficacy of the drug products. Looking at the criticality of understanding the regulatory authority’s expectations and to determine efficient execution of the cleaning process, CPhI is organising a Cleaning Validation Workshop which is scheduled from June 23 – 24, 2016 in Mumbai.


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July 2016

Pharmaceutical Supply Chain Integrity - Good Distribution Practices (GDP)

July 4-5, 2016

Venue to be announced shortly, Shanghai, Non-U.S., China

Attend this workshop in China to learn new GDP guideline by PIC/S. You will also learn GDP applications, GDP (GWP) regulations, GDP guidelines, cold chain management and risk management. This course will be taught in Chinese language.


DCAT Sharp Sourcing 2016

July 12-12, 2016

Hyatt Regency Hotel, New Brunswick, NJ, United States

What does it take to move Sourcing and Procurement Organizations to the next level? How can pharmaceutical companies, contract service providers, and suppliers collaborate for mutual long-term gain? The answers to these questions will be addressed at DCAT Sharp Sourcing 2016, a conference and networking event that provides peer and customer insight on the best practices and practical ways for optimizing pharmaceutical manufacturing and supply networks. Presented by the Drug, Chemical & Associated Technologies Association (DCAT), the event is designed for senior to mid-level executives engaged in sourcing, purchasing, procurement, supply management, and external manufacturing and their business counterparts on the supply side.


FDA's Regulation of Regenerative Medicine including Stem Cell Treatments, Tissue Engineering and Gene Therapies

July 14-15, 2016

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

This seminar will teach you the use of stem cells in medicine. You will learn fundamentals of stem cells, FDA regulatory approval, FDA guidance, stem cells technologies, commercialization of stem cell technologies and more.


Seminar on Why is FDA at my Facility, and what do I do During an Inspection

July 18-19, 2016

WILL BE ANNOUNCED SOON, Singapore, Non-U.S., Singapore

Course "Why is FDA at my Facility, and What do I do During an Inspection" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Many regulated companies preparing for FDA inspections are not prepared and the outcome can be negative as we see all the time with enforcement actions. This seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no matter if you are a Class I, II, III device or a pharmaceutical or biologics manufacturer. This presentation will review and emphasize the do's and don'ts and cardinal rules as to interviewing, how to respond, reviewing documentation, etiquette, use of certain words, body language, responding to questions/requests, etc., and certainly replying to 483's and Warning Letters. Emphasis is placed on the company's SOP on dealing with inspectors and knowing how to be prepared, proactive...and being able to defend and justify... and what it takes to achieve a favorable outcome. This seminar provides background and understanding of the role played by the Agency, its administrative and enforcement powers. It takes the participant step by step through the entire inspection process and describes various types of inspections. Who will benefit: Industries • FDA regulated Industries o Medical Device o Pharmaceuticals o Clinical • Dietary Supplements o Food o Nutraceutical • Healthcare IT o Technical Services o Validation o Engineering Departments • Top and Middle Management • Quality Assurance/Management • Compliance Management • Manufacturing • Laboratory • Regulatory Affairs • Information Technology • Marketing & Sales • Operations • Research & Development Types of facilities: • Manufacturing facilities • Contract manufacturing facilities • Distributors • Packaging, Labeling • API Suppliers • Laboratories • Importers • Documentation Management Agenda: Day 1 Schedule Lecture 1: How a firm should prepare for an FDA inspection Lecture 2: Ways to train employees in view of the inspection Lecture 3: How to ensure that required documentation is in place Lecture 4: How to interact with the investigator-DO's and DON'T's Lecture 5: What companies should do when the inspection ends Lecture 6: How to reply to 483's and warning letters Lecture 7: Legal implications of non-compliance Lecture 8: Post inspection actions Day 2 Schedule Lecture 1: Why inspections are conducted and by what statutory authority Lecture 2: The emphasis on systems-based inspections...and the IOM and other crucial FDA reference documents Lecture 3: What is subject to FDA purview and what's off-limits Lecture 4: Understand and apply the do's and don'ts and comprehend that preparation is the key to success Lecture 5: What are the prohibited "Acts" and the enforcement categories that you need to deal with Lecture 6: What you need to know and do to prepare for, during and even after the inspection...and why your inspection response team is key Lecture 7: The company's Inspection Plan (SOP) can make or break the inspection depending on how to use it and training your personnel Lecture 8: How to respond to findings and facilitating the documentation and remediation process...and reaching final closure Lecture 9: Define clear responsibilities, roles and goals for personnel involved in SOP development 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. He manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations and commercial opportunities and develops strategies for governmental approval to introduce new products to market, provides guidance on regulatory and compliance requirements and prepares/reviews worldwide submissions/dossiers/technical files and addresses global regulatory requirements. Background encompasses broad capabilities in quality systems, validation, regulatory affairs, compliance, auditing, interfacing with the regulatory agencies, addressing enforcement actions and mitigating compliance exposure for companies via remediation, compliance engineering support, post-marketing surveillance and vigilance reporting; clinical affairs, establish and/or remediate Quality Management and documentation systems for GxP compliance; preparation for ISO 13485 registration and CE Mark; and multi-country product registrations and licensing; and working with Notified Bodies, and AR's. David manages regulatory problems (e.g. AE's, MDRs, Agency enforcement, complaints/investigations, field alerts/recalls) related to development, manufacturing, and commercialization, and recommends action to senior leadership to ensure effective resolution for manufacturers to achieve sustainable and proven compliant systems. This is based on analyzing the benefits/risks for informed decision-making and interprets the regulatory precedents and new legislation. He strives to optimize business performance through proactive strategies to mitigate compliance exposure by providing strategic and tactical solutions that facilitate the achievement of regulatory and quality milestones. David has been previously affiliated with well-known device manufacturers and service providers, including a global CRO and has served in various quality, regulatory and compliance management and advisory capacities with increasing responsibilities. David is an industry speaker and author of technical and compliance related topics published in industry journals. Please refer to his profile provided herein for additional information about his background and areas of interest and focus. Location: Singapore Date: July 18th & 19th, 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 16, 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 16, 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://bit.ly/During-an-Inspection Follow on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel


Effective Quality Oversight of Pharmaceutical Contract Manufacturing Organizations (CMOs)

July 21-22, 2016

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

This seminar will give you complete oversight of CMOs from start to finish. You will learn CMO selection, qualification, quality agreement, CMO operations, CMO records, CMO audit ,project management and more.


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.


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.


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.


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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


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.


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.


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October 2016

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.


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


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.


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.


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.


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.


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.


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

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.


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