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Session 2 - ICH Guideline E5, 17 Training
Session Chair(s)
Ryuta Nakamura, PHD
Review Director, Office of New Drug II
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Speaker(s)
E5/E17: Ethnic Factors in the Acceptability of Foreign Clinical Data; Planning and Design of Multi-reginal Clinical Trials -1 (Regulatory Agency’s viewpoint)
Yoko Aoi, PHD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Coordination Director - Office of Review Management
E5/E17: Ethnic Factors in the Acceptability of Foreign Clinical Data; Planning and Design of Multi-regional Clinical Trials -2 (Industry’s viewpoint)
Osamu Komiyama
Pfizer R&D Japan G.K., Japan
Senior Manager, Statistical Research & Data Science