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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)
Yuki Ando, PhD
Principal Senior Scientist for Biostatistics, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Overview of ICH E9 (R1)
Masayo Miyata
Group Manager, Trial Lead Department, R&D Div., Janssen Pharmaceutical K.K., Japan
Practical Issues
Satoru Fukinbara, PhD
Officer, Senior Director, Global Head of Data Science Director of Clinical Devel, Ono Pharmaceutical Co., Ltd., Japan
Missing Data, Appropriate Statistical Analytical Methods,Appropriate Sensitivity Tests
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