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[V1-S5] Future Drug Development with Multi-Regional Clinical Trials (MRCT) Based on ICH E17 Guideline
Session Chair(s)
Ryuta Nakamura, PhD
Review Director, Office of New Drug II
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
In order to perform efficient globalized drug development, it is important to take into consideration an international harmonization. The ICH E17 guideline has been discussed to establish an international harmonized guideline focusing on designing/planning multi-regional clinical trials. In this session, recent regulatory experiences and the direction of ICH E17 guidelines including the current situation will be presented by a PMDA representative. How the ICH E17 guideline affects a future drug development strategy will also be presented by industry representatives. In a panel discussion, various topics such as the future direction of drug development and roles of Japan in Asia will be discussed.
Speaker(s)
Recent Review Experiences of MRCT Data and a Direction of ICH E17 Guideline
Shuji Kamada
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Reviewer, Office of New Drug V
Future Drug Development and Impacts of ICH E17 Guideline: JPMA Perspective
Osamu Komiyama
Pfizer R&D Japan G.K., Japan
Senior Manager, Statistical Research & Data Science
Future Drug Development Strategies and Impact of ICH E17 Guideline: Pharmaceutical Company Perspective
Laurie Letvak, MD
Novartis Pharmaceuticals Corporation, United States
Head Clinical Policy and Medical Ethics
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