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Session 0201: THE PRACTICE OF NEW DRUG IN FIRST-IN-HUMAN STUDIES IN CHINA
Session Chair(s)
Jian Peng
Clinical Research Director
Sanofi (China), China
First-in-Human (FIH) studies are part of the exploratory phase of drug development and represent significant milestone in the clinical development of new drugs. The session shares several practical considerations from CFDA/CDE experts’ point of view about the China FIH studies, as well as discusses regulatory and clinical issues and experience in FIH studies.
Speaker(s)
CDE Reviewer’s View on FIM Studies
Representative Invited
CDE, Taiwan
Regulatory Requirements for FIM Clinical Studies Focus on GCP, CFDA
Representative Invited
China
Case Studies of FIH on Innovative Drug Development in China
Representative Invited
United States
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