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SS01: Utilization of Registry Data for Regulatory Application - Implementation as External Control Arm, Post-Marketing Efficacy Assessment -
Session Chair(s)
Hideki Oi, RPH
Clinical Research Center
Kyorin University Hospital, Japan
Hideharu Yamamoto, PHD
Chairperson Data Science Expert Committee Drug Evaluation Committee
Chugai Pharmaceutical Co., Ltd., Japan
Speaker(s)
Yuki Ando, PHD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Principal Senior Scientist for Biostatistics
Taro Shibata, MSC
Center for Research Administration and Support, National Cancer Center, Japan
Chief, Biostatistics Division
Hideki Oi, RPH
Kyorin University Hospital, Japan
Clinical Research Center
Yoshiaki Nakamura, MD, PHD
National Cancer Center Hospital East, Japan
Translational Research Support Section/Department of Gastrointestinal Oncology
Nobushige Matsuoka, PHD
Pfizer R&D Japan G.K., Japan
Group Lead, Clinical Statistics Group 2, Biometrics & Data Management
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