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Session 3: Innovative Technologies
Session Chair(s)
Peter Richardson
Senior Quality Specialist, European Medicines Agency, Netherlands
This session will look at innovative technologies for the manufacture of pharmaceutical products, with a focus on continuous manufacture (CM). Over recent years, CM has become of increasing interest for manufacturers, offering many potential benefits. Experience is growing in this field and a number of CM processes have been approved by regulators and with many companies considering applying this process technology, this will continue to grow. Challenges such as batch definition and traceability, dynamic control strategies, use of Process Analytical Technologies, validation strategies, and specifications are some of the areas which can require new perspectives from both industry and regulators. The session will give broad ranging perspectives from regulators and industry participants for small and large molecule examples.
Speaker(s)
Peter Richardson
Senior Quality Specialist, European Medicines Agency, Netherlands
Session introduction and EU Regulatory Perspectives on Innovative Technologies
Sau Lee, PHD
Deputy Super Office Director, OPQ, CDER, FDA, United States
US FDA Regulatory Perspectives on Innovative Technologies
Diane J. Zezza
Vice President and Global Head, Regulatory CMC, Novartis Pharmaceuticals Corporation, United States
Industry Perspective for Implementing Continuous Manufacturing for Small Molecules
Nick Keener, PHD
Director of Process Development, Amgen, United States
Industry Perspective for Implementing Continuous Manufacturing for Biopharmaceuticals
Yoshihiro Matsuda, DrMed
Principal Senior Scientist (for Quality), Pharmacist, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Panelist (Joining Session Speakers)
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