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Session 6A: Perspectives on Continuous Manufacturing Approaches and Recent Developments in the Quality of Pharmaceuticals
Session Chair(s)
Loretta Del Bosco
Director, Regulatory Affairs Quality Assurance Operations, AbbVie Corporation, Canada
This session will provide the Regulator and Industry perspectives on continuous manufacturing approaches. From initial formulation and process development activities to manufacturing, the session will highlight key lessons learned and future opportunities in this exciting area of pharmaceutical products. This session will also have updates from Health Canada on several key regulatory Quality guidelines for the regulation of pharmaceuticals.
Speaker(s)
John Groskoph, MBA
Executive Director, Global CMC, Pfizer Inc, United States
A Risk-Based Approach to Development and Manufacture of a New Chemical Entity Using Continuous Manufacturing (PCMM)
Daniel Blackwood
Director, Pharm Science Technology and Innovation, Pfizer Inc, United States
Speaker
Daniela I. Decina, MSC
Senior Director, Regulatory Affairs, CMC, Mapi Group, Canada
Continuous Manufacturing of Biological Therapeutics: Current Technology Trends and Their Regulatory Impact
Alison Ingham, PHD
Team Leader, Generic Drugs Quality Division, Health Canada, Canada
Update on Health Canada's Quality Guidance for NDSs and ANDSs and on the Use of EDQM's Certificates of Suitability (CEPs) within the Canadian Regulatory Framework