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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
Principal Senior Scientist for Biostatistics, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Taro Shibata, MSc
Chief, Biostatistics Division, Center for Research Administration and Support, National Cancer Center, Japan
Hideki Oi, RPh
Clinical Research Center, Kyorin University Hospital, Japan
Yoshiaki Nakamura, MD, PhD
Translational Research Support Section/Department of Gastrointestinal Oncology, National Cancer Center Hospital East, Japan
Nobushige Matsuoka, PhD
Group Lead, Clinical Statistics Group 2, Biometrics & Data Management, Pfizer R&D Japan G.K., Japan
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