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The 7th DIA China Annual Meeting

Session 1005 Generic Drug Forum - I - Global Requirements and Regulatory Initiatives

Session Chair(s)

Shaoyu Chen, JD

Shaoyu Chen, JD

  • Managing Director, China Food and Drug Practice; Partner
  • Covington & Burling LLP, China

U.S. Generic Drug Framework

Speaker(s)

Xuejie Dou

Xuejie Dou

  • Senior Director, Quality
  • Xinhua Pharmaceutical, China
Keith Flanagan

U.S. Generic Drug Framework

Keith Flanagan

  • Director, and head of Office of Generic Drug Policy (OGDP)
  • Office of Generic Drugs, CDER, FDA, China
Chia-Ling Hsiao

Chia-Ling Hsiao

  • PK Reviewer
  • Center for Drug Evaluation, Taiwan
Toru Yamaguchi

Toru Yamaguchi

  • Reviewer Pharmacist, Office of OTC/Generic Drugs
  • Pharmaceuticals and Medical Devices Agency (PMDA), Japan

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