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Session 0301: HOW GxP IMPACTS THE MEDICAL PRODUCT REVIEW AND APPROVAL DECISION? (PART I)
Session Chair(s)
Florence Houn, MD, MPH, FACP
Consultant
Florence Houn MD MPH LLC, United States
This session will illustrate key principles regarding regulators’ approach to how compliance issues with GxP impacts medical product application decision-making and how the application review impacts GxP inspections. These principles are based on FDA, industry, and CFDA experiences. Current and past decision makers on drug applications will share their views on how compliance with GxP affects their decision making based on previous cases in the public domain.
Speaker(s)
Key Principles on GxP Impact on Medical Product Review & Approval Decision-Making: The Medical Reviewer’s Perspective
Mark Goldberger, MD, MPH
Mark Goldberger MD MPH LLC, United States
CMC Reviewer’s Role in Pre-approval Manufacturing Site Inspections
Chi-Wan Chen, PhD
Pfizer, Inc., United States
CFDA Current and Future Directions
Zhimin Yang, MD
National Medical Products Administration (NMPA), China
Deputy Director, Center for Drug Evaluation
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