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Session Chair(s)
Akio Uemura, PHD
Senior Advisor
AU Consulting, Co., Japan
Learning Objective : Review scientific evidences which show or do not show acceptability of clinical data with ethnic differences; Review history of the regulations and current understanding in accepting clinical trial data generated in foreign populations; Describe future international regulations for handling ethnic factors.
Speaker(s)
Ethnic Similarities and Differences: Facts and Interpretations
Yoshiaki Uyama, PHD, MS, RPH
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Associate Executive Director
Utilization of Asian Clinical Trial Data for Drug Development in Korea: Investigator’s Perspective
In-Jin Jang, MD, PHD
College of Medicine, Seoul National University, Korea, Republic of
Professor
New Drug Application in China: Value of Foreign Data
Chwen-Cheng Chen, MD, PHD
JN Biopharma Consulting, United States
CEO
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