DIA EUROPE 2018

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Update on PMDA’s Activities

Session Chair(s)

Toshiyoshi Tominaga, PhD

Project Professor

Keio University Hospital, 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

Cabinet Office, Japan

Health Policy Director, National Healthcare Policy Secretariat

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

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