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PMDA Town Hall
Session Chair(s)
Toshiyoshi Tominaga, PHD
Life Science Department, Advisor
SunFlare Co., Ltd, 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)
Recent Regulatory Topics and International Cooperation of MHLW
Kazuhiko Mori, PHD, MSC
Japan Pharmaceutical Manufacturers Association (JPMA), Japan
Former Executive Director
PMDA’s Regulatory Science and Innovation
Tatsuya Kondo, MD, PHD
SH Medical Excellence JAPAN, Japan
President
Real-World Data Utilization: A New Approach to Pharmacovigilance
Shinobu Uzu, PHD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Senior Executive Director