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Update on PMDA’s Activities
Session Chair(s)
Toshiyoshi Tominaga, PHD
Life Science Department, Advisor
SunFlare Co., Ltd, Japan
PMDA will share the latest details regarding its policies and initiatives and other related strategic directives. The goal of the session will be to keep participants informed of the agency’s handling of the most critical issues.
Learning Objective : (1) To raise awareness of the latest information regarding PMDA and Japanese regulations (2) To foster dialogue between participants and senior PMDA officials concerning drug/device regulatory concerns
Speaker(s)
MHLW and PMDA’s General Policies on Regulating Innovative Products
Nobumasa Nakashima
Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Japan
Professor
PMDA’s Innovation and Review System in Japan
Tatsuya Kondo, MD, PHD
SH Medical Excellence JAPAN, Japan
President
New Pharmacovigilance Approach; Use of Real World Data
Shinobu Uzu, PHD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Senior Executive Director