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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
Nina S. Cauchon, PhD
Amgen, United States
Director Regulatory Affairs CMC
Panelist
Sarah Pope Miksinski, PhD
Gilead Sciences, United States
Executive Director, CMC Regulatory Affairs
Panelist
Eric Jayjock, PhD
Patheon, A Part of Thermo Fisher Scientific, United States
Director, Continuous Manufacturing
Panelist
Geoffrey Wu, PhD
FDA, United States
Deputy Director, Office of Lifecycle Drug Products, OPQ, CDER, FDA
Panelist
Paul Seo, PhD
FDA, United States
Director, Division of Biopharmaceutics, ONDP, OPQ, CDER
Panelist
Christine Moore, PhD
Organon & Co., United States
Executive Director, Global External Advocacy and Standards
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