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[Session 4] Changes and Benefits ICH E17 will Bring about
Session Chair(s)
Yoshiaki Uyama, PhD, MS, RPh
Associate Executive Director
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
The ICH-E17 guideline “General principle on planning/designing Multi-Regional Clinical Trials” is currently under consideration. This guideline suggests pooling some regions at the design stage if subjects in those regions are thought to be similar enough with respect to intrinsic and/or extrinsic factors. East Asia is expected to be effectively utilized as a pooled region given the similarities among countries. This guideline will have important implications in sample size allocation or selecting the region where the clinical study is to be conducted. In this session, speakers from PMDA and industry will present the changes that implementing this guideline will bring about, including changes in drug development strategy and specific examples of wise use of this guideline.
Speaker(s)
Changes and Benefits ICH E17 Will Bring About - Regulatory Perspective -
Shuji Kamada
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Reviewer, Office of New Drug V
Points to be Considered in Order to Implement E17 Guideline - Industry Perspective
Osamu Komiyama
Pfizer R&D Japan G.K., Japan
Senior Manager, Statistical Research & Data Science