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Saturday, June 19 • 12:00pm - 1:00pm
#532 OD: PMDA Town Hall

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Component Type: Forum
Level: Intermediate

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 will introduce its efforts around "4Fs" including those for COVID19.

Learning Objectives

Describe the latest information regarding PMDA and Japanese regulations; Discuss how to foster dialogue between participants and senior PMDA officials concerning drug/device regulatory challenges.


Nobumasa Nakashima, PhD


Fumi Yamamoto

Yasuhiro Fujiwara, MD, PhD

Kenichi Tamiya, MSc, RPh

avatar for Nobumasa Nakashima

Nobumasa Nakashima

Associate Executive Director for International Programs, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Nakashima joined Ministry of Health, Labour and Welfare (MHLW) in 1992. He spent his career in the international field such as WHO and OECD, not only in the domestic field. He worked as International Planning Director at MHLW since 2014, Director of Office of International Regulatory... 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 →

Kenichi Tamiya

Associate Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
avatar for Fumi Yamamoto

Fumi Yamamoto

Councilor for Pharmaceutical Affairs, Minister’s Secretariat, Ministry of Health, Labour and Welfare (MHLW), Japan
After graduating the Graduate School of Pharmaceutical Sciences of the University of Tokyo in 1988, Ms. Yamamoto entered Ministry of Health, Labour and Welfare in the same year. Ms. Yamamoto has served in numerous positions on drug regulation and food safety, including Director, Office... Read More →

Saturday June 19, 2021 12:00pm - 1:00pm EDT
TBD Virtual Event Horsham, PA 19044
  09: Regulatory, Forum |   20: Early Access Content, Forum