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Session 4: Control Strategy Approaches for Drug Substance and Drug Product
Session Chair(s)
Elaine Morefield, PhD, RPh
Vice President, Regulatory Affairs
VaxForm, LLC., United States
This session will look at approaches to developing, maintaining, and improving the control strategy throughout the product life cycle, from a drug substance, drug product, and regulatory perspective. Following the presentations, a discussion of control strategy approaches in described situations, will allow the audience to share their insights and approaches and to ask questions of the panel members.
Speaker(s)
Life Cycle Approach to Drug Substance Development
Nick Thomson
Pfizer Ltd., US, United States
Director Technology API, Chemical Research and Development
Development and Continual Improvement of the Drug Product Control Strategy
Stephen M. Tyler
AbbVie, United States
Director, Quality Assurance, Global Pharmaceutical Operations
Regulatory Considerations for the Development of Control Strategy
Sarah Pope Miksinski, PhD
Gilead Sciences, United States
Executive Director, CMC Regulatory Affairs
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