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Thursday, June 18 • 5:00pm - 6:00pm
#550 OD: ON DEMAND - PMDA Town Hall: The Path of a New Chief Executive Since His Appointment

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Component Type: Session
Level: Intermediate

Last year, Dr. Yasuhiro Fujiwara, a new chief executive, has announced a new policy “4Fs”. PMDA is working effectively toward the realization of his goal. In this session, PMDA will share the latest details regarding its policies and initiatives.

Learning Objectives

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


Nobumasa Nakashima, PhD


Yasuhiro Fujiwara, MD, PhD

Hiroyuki Arai, PhD

Naoyuki Yasuda, MS

avatar for Nobumasa Nakashima

Nobumasa Nakashima

Associate Executive Director for International Programs and Asia Training Centre, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Nakashima holds the position of Associate Executive Director for International Programs and Asia Training Centre (ATC) at PMDA since January 2020. Before this position, he had joined MHLW in April 1992, where he worked as Director of Office of International Regulatory Affairs... Read More →
avatar for Hiroyuki Arai

Hiroyuki Arai

Director of Center for Product Evaluation and Center of Regulatory Science, Pharmaceuticals and Medical Devices Agency (PMDA)
Dr. ARAI Hiroyuki is currently Executive Director and Director of Center for Product Evaluation, Pharmaceuticals and Medical Devices Agency (PMDA). He oversees all aspects of medical product evaluation including review, scientific advice and standard compliance of pharmaceuticals... Read More →
avatar for Yasuhiro Fujiwara

Yasuhiro Fujiwara

Chief Executive, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. FUJIWARA Yasuhiro has been Chief Executive, PMDA since April 2019. He is a medical oncologist, specializing in breast cancer. He was previously Director-General, Strategic Planning Bureau of the National Cancer Center, and the Deputy Director of the Hospital (Research), National... Read More →
avatar for Naoyuki Yasuda

Naoyuki Yasuda

Director, Office of International Regulatory Affairs, Ministry of Health, Labour and Welfare (MHLW)
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 →

Thursday June 18, 2020 5:00pm - 6:00pm EDT
TBD Virtual Event Horsham, PA 19044
  09: Regulatory, Session