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Session 1005 Generic Drug Forum - I - Global Requirements and Regulatory Initiatives
Session Chair(s)
Shaoyu Chen, JD
Managing Director, China Food and Drug Practice; Partner
Covington & Burling LLP, China
Speaker(s)
Xuejie Dou
Xinhua Pharmaceutical, China
Senior Director, Quality
U.S. Generic Drug Framework
Keith J. Flanagan
FDA, United States
Director, Office of New Drug Policy, CDER
Chia-Ling Hsiao
Center for Drug Evaluation, Taiwan, China
Director, Division of Pharmaceutical Science
Toru Yamaguchi
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Reviewer Pharmacist, Office of OTC/Generic Drugs