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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
Director, Department of Clinical Data Science,
National Center of Neurology and Psychiatry (NCNP), Japan
Hideharu Yamamoto, PhD
Biostatistics Deputy Dept Manage, Biometrics Dept
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
National Center of Neurology and Psychiatry (NCNP), Japan
Director, Department of Clinical Data Science,
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
Manage, Biometrics & Data Management