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PMDA Town Hall
Session Chair(s)
Toshiyoshi Tominaga, PHD
Life Science Department, Advisor, Sunflare, Japan
During this forum, PMDA will share its activities to promote high-quality, innovative medical research and clinical trials meeting or exceeding international standards as well as its advocacy for the application of “Big Data” in medical practice. PMDA will present the latest details of regulatory aspects regarding its three primary services (review, safety, and the adverse event relief system (the “PMDA Safety Triangle”)) in addition to updates on its advanced product review system, regulatory capacity building activities, and international collaborations.
Learning Objective : Discuss the latest information on Japanese regulatory initiatives and regulations; Identify how to update SAKIGAKE designation, MID-NET projects, etc. which were introduced in the PMDA Town Hall session in DIA the previous year.
Speaker(s)
Kazuhiko Mori, PHD, MSC
Business Manager, "Toyama, the Silicon Valley of Medicine" Creative Consortium Management Office, Japan
Tatsuya Kondo, MD, PHD
President, SH Medical Excellence JAPAN, Japan
Shinobu Uzu, PHD
Senior Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
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