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[V4-S6] ICH E9 (R1): Discussion on the Appropriate Estimands for Clinical Trials
Session Chair(s)
Hideki Suganami, PhD
Global Data Science Center, Head
Kowa Company, Ltd., Japan
A Regulatory Perspective on the Clinical Development of Combination Products
Speaker(s)
Overview of ICH E9 (R1)
Yuki Ando, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Principal Senior Scientist for Biostatistics
Practical Issues
Masayo Miyata
Janssen Pharmaceutical K.K., Japan
Group Manager, Trial Lead Department, R&D Div.
Missing Data, Appropriate Statistical Analytical Methods,Appropriate Sensitivity Tests
Satoru Fukinbara, PhD
Ono Pharmaceutical Co., Ltd., Japan
Officer, Senior Director, Global Head of Data Science Director of Clinical Devel