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Update on PMDA’s Activities

Track:
Drug Development and Regulatory Approval - Reference Points around the Globe or Globalisation?

Day & Time:
April 18, 10:30AM - 12:00PM (Central Europe Standard Time)

Session Number:
S0801

Level:
Intermediate

Type:
Session

Title:
Update on PMDA’s Activities

Chair(s):
Toshiyoshi Tominaga, PhD
Associate Executive Director (for International Programs)
Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Description:
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(s):
(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

Presentation(s) & Speaker(s):
MHLW and PMDA’s General Policies on Regulating Innovative Products
Nobumasa Nakashima, PhD
Director, Office of International Regulatory Affairs
Ministry of Health, Labour and Welfare (MHLW), Japan

PMDA’s Innovation and Review System in Japan
Tatsuya Kondo, MD, PhD
Chief Executive
Pharmaceuticals and Medical Devices Agency (PMDA), Japan

New Pharmacovigilance Approach; Use of Real World Data
Shinobu Uzu, MSc
Chief Safety Officer
Pharmaceuticals and Medical Devices Agency (PMDA), Japan