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S01 : Utilizing DX: The Global and Japanese Status of Clinical Trial Data Concepts Pioneered by Generative AI and ICH M11
Session Chair(s)
Satoru Tsuchiya, MSc
VP, Global Data Design Office , Sumitomo Pharma Co., Ltd. , Japan
Speaker(s)
Y. Veronica Pei, MD, MPH
Deputy Division Director, FDA, United States
Yuji Matsukura
Director, Office of Vaccine and Blood Products, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Mitzi Allred, PhD
Director, Clinical Operations, United States
Yoshihiro Aoyagi, MS
Manager, Department of Medical Information, National Cancer Center Hospital East, Japan
Guillaume Schoch
Regulatory Leader in Data and Content Chapter, People Leader, F. Hoffmann-La Roche Ltd, Switzerland