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Session 6B: Control Strategy - Lessons Learned
Session Chair(s)
Elaine Morefield, PhD, RPh
Vice President, Regulatory Affairs
VaxForm, LLC., United States
This session will cover industry and regulator experiences with implementing integrated control strategies for small molecule and biologic products. Control strategy discussion may include process controls, in process tests, design space and real time release testing. Drug substance and drug product considerations will be covered. Parenteral and solid oral dosage form examples will be presented.
Speaker(s)
Regulatory Considerations for Control Strategy
Elaine Morefield, PhD, RPh
VaxForm, LLC., United States
Vice President, Regulatory Affairs
Experiences in Establishing a Commercial Control Strategy for a Small Molecule Product
John Groskoph, MBA
Pfizer Inc, United States
Executive Director, Global CMC
Considerations for Establishing a Control Strategy for a Biologic Product Throughout Development
Allison Wolf, MS
Eli Lilly & Company, United States
Research Scientist, Global Regulatory Affairs CM&C
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