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Tuesday, June 21 • 4:15pm - 5:15pm
#275.1: PMDA Town Hall

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-535-L04-P ; CME 1.00; RN 1.00

PMDA’s activity is based on "4Fs" (Patient First, Access First, Safety First, Asia First) as priority policy, which Dr. Fujiwara, chief executive, has set up. In this session, PMDA introduce our efforts on "4Fs" including the challenge to COVID-19.

Learning Objectives

Discuss the latest information regarding PMDA and Japanese regulations; Describe the dialogue between participants and senior PMDA officials concerning issues on drug/device regulation.


Nobumasa Nakashima, PhD


Naoyuki Yasuda, MSc

Yasuhiro Fujiwara, MD, PhD

Hiroyuki Arai, PhD

avatar for Hiroyuki Arai

Hiroyuki Arai

Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Hiroyuki Arai has served as an Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA) since April 2020. Before joining PMDA, he was a professor of Department of Health Chemistry, Graduate School of Pharmaceutical Sciences at the University of Tokyo (2000-2019... Read More →
avatar for Yasuhiro Fujiwara

Yasuhiro Fujiwara

Chief Executive, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Yasuhiro Fujiwara was previously Director-General, Strategic Planning Bureau of the National Cancer Center, and the Deputy Director of the Hospital (Research), National Cancer Center Hospital. He is a medical oncologist, specializing in breast cancer. Before joining NCCH, he was... Read More →
avatar for Naoyuki Yasuda

Naoyuki Yasuda

Director, Office of International Regulatory Affairs, Ministry of Health, Labour and Welfare (MHLW), Japan
Mr. Naoyuki Yasuda graduated from Osaka University in 1991. He careered industrial policy, industrial chemicals assessment, medical devices revaluation, international cooperation on narcotics and psychotropics, blood/blood product safety and vaccine supply and overall pharmaceuticals... Read More →

Tuesday June 21, 2022 4:15pm - 5:15pm CDT
Room 183 B McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  09: Regulatory, Forum