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Where Quality Meets Safety and Efficacy: A Conversation with CMC Experts
Session Chair(s)
Bowman Cox
Executive Editor, Manufacturing, Informa Pharma Intelligence, United States
In this forum, panelists will discuss how to define quality on patient relevance rather than on ever-tightening process and analytical capabilities that can reduce efficiency and limit patient access to drugs.
Learning Objective : Identify purpose-driven as opposed to process-driven approaches to establishing specifications; Define how to apply toxicological concepts to manufacturing process parameters; Describe how to justify more robust design spaces.
Speaker(s)
Panelist
Director Regulatory Affairs CMC, Amgen, United States
Panelist
Executive Director, CMC Regulatory Affairs, Gilead Sciences, United States
Panelist
Director, Continuous Manufacturing, Patheon, A Part of Thermo Fisher Scientific, United States
Panelist
Deputy Director, Office of Lifecycle Drug Products, OPQ, CDER, FDA, FDA, United States
Panelist
Director, Division of Biopharmaceutics, ONDP, OPQ, CDER, FDA, United States
Panelist
Executive Director, Global External Advocacy and Standards, Organon & Co., United States
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