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Session 0302: HOW GxP IMPACTS THE MEDICAL PRODUCT REVIEW AND APPROVAL DECISION? (PART II)
Session Chair(s)
Yi Feng
SVP, Medical and Reg Affairs
Fountain Medical Development Ltd., China
This session will build on the previous session and expand on key principles regarding the impact of GxP compliance on medical product decision-making based on FDA, industry, and TFDA 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)
GLP Excellence and Impact on Regulatory Review and Approval
Dylan YAO, MD, PhD
Joinn Laboratories, Inc., China
Senior Vice President and CSO
GLP Excellence and Impact on Regulatory Review and Approval
Representative Invited
Mexico
Biologics - Device Reviewer’s Perspective on the GMP
Gang Wang, PhD
U.S.FDA China Office, China
TFDA Current and Future Directions
Lih-Jiuan Hsu
Center for Drug Evaluation, Taiwan, Taiwan
Deputy Executive Director
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