25th Annual EuroMeeting

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JAPANESE REGULATORY SESSION – PMDA UPDATE

Session Chair(s)

Nobumasa Nakashima

Health Policy Director, National Healthcare Policy Secretariat

Cabinet Office, Japan

PMDA will explain the latest activities and Japanese regulation, and answer questions from the audience about PMDA’s current situation, activities and future initiatives / challenges in reviewing and managing drugs through their life cycle.

Learning Objective : (1)To know the latest situation of PMDA and Japanese regulation (2)To have a dialogue with PMDA senior officials on Japanese drug regulatory issues

Speaker(s)

PMDA Update: Its current situation and future direction

Tatsuya Kondo, MD, PhD

SH Medical Excellence JAPAN, Japan

President

PMDA’s Efforts in Medical Innovation – Regulatory Science & Science Board

Hideo Utsumi, PhD

Kyushu University, Japan

Professor, Research Managing Director,Innovation Center for Medical Redox Naviga

PMDA’s Efforts in Safety Measures - Risk Management Plan(RMP) in Japan -

Kazuhiko Mori, PhD, MSc

Japan Pharmaceutical Manufacturers Association (JPMA), Japan

Senior Managing Director

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