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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)
A Risk-Based Approach to Development and Manufacture of a New Chemical Entity Using Continuous Manufacturing (PCMM)
John Groskoph, MBA
Pfizer Inc, United States
Executive Director, Global CMC
Speaker
Daniel Blackwood
Pfizer Inc, United States
Director, Pharm Science Technology and Innovation
Continuous Manufacturing of Biological Therapeutics: Current Technology Trends and Their Regulatory Impact
Daniela I. Decina, MSc
Mapi Group, Canada
Senior Director, Regulatory Affairs, CMC
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
Alison Ingham, PhD
Health Canada, Canada
Team Leader, Generic Drugs Quality Division
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