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Session 3: Innovative Technologies
Session Chair(s)
Peter Richardson, PhD
Head of Quality, Specialised Scientific Disciplines Department
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)
Session introduction and EU Regulatory Perspectives on Innovative Technologies
Peter Richardson, PhD
European Medicines Agency, Netherlands
Head of Quality, Specialised Scientific Disciplines Department
US FDA Regulatory Perspectives on Innovative Technologies
Sau L Lee, PhD
FDA, United States
Deputy Super Office Director, OPQ, CDER
Industry Perspective for Implementing Continuous Manufacturing for Small Molecules
Diane J. Zezza
Novartis Pharmaceuticals Corporation, United States
Vice President and Global Head, Regulatory CMC
Industry Perspective for Implementing Continuous Manufacturing for Biopharmaceuticals
Nick Keener, PhD
Amgen, United States
Director of Process Development
Panelist (Joining Session Speakers)
Yoshihiro Matsuda, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Senior Scientist (for Quality), Pharmacist