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Session 1: Perspectives of Respective Regulatory Agencies in Clinical Data Evaluation for Drug Approval
Session Chair(s)
Mark Bach, MD, PhD
Vice President, Office of the Chief Medical Officer
Johnson & Johnson, United States
Yasuto Otsubo
Review Director, Office of New Drug II
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Utilization of East Asian Clinical Data in Asian Drug Development - Part 1: In the first part, we will take a close look at the recent regulatory agency collaboration in East Asia, and would like to ask agency representatives from China, Korea, Taiwan and Japan to present key factors which the regulatory agency think very important when they assess the East Asia multi regional clinical trial (MRCT) data acceptability for NDA, which have been generated in respective regions. We would also like to ask them to think about how those key factors would be changing in the near future from respective stand point.
Speaker(s)
Clinical Data Evaluation for Drug Approval - Observations from China
Ling Su, PhD
Yeehong Business School, China
Research Fellow
Clinical Data Evaluation for Drug Approval : Korean Perspective
Mee Ryung Ahn, PhD
Ministry of Food and Drug Safety, Korea, Republic of
Director
Clinical Data Evaluation for Drug Approval in Taiwan - Focusing on BSE
Li-Li Su
Center for Drug Evaluation, Taiwan
Reviewer, Division of Pharmaceutical Sciences
PMDA’s Perspectives in Global Clinical Data Evaluation for Drug Approval
Yoshiaki Uyama, PhD, MS, RPh
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Associate Executive Director