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Tuesday, June 25 • 10:30am - 11:30am
#241: PMDA Town Hall

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-600-L04-P; CME 1.00; IACET 1.00; RN 1.00

In this forum, PMDA will share the latest details regarding its policies and initiatives and other related strategic directives.Three senior level representatives from PMDA and MHLW will introduce the latest situations regarding scientific review systems, regulatory capacity building activities, and the current international collaboration.

Learning Objectives

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

Chair

Nobumasa Nakashima, PhD

Speaker

Regulatory Updates: Facilitating Early Patient Access
Kazuhiko Mori, MSc

The Future of PMDA
Yasuhiro Fujiwara, MD, PhD

Current Initiatives of PMDA Regulatory Science Center
Hiroyuki Arai, PhD



Speakers
avatar for Yasuhiro Fujiwara

Yasuhiro Fujiwara

Chief Exective, Pharmaceuticals and Medical Devices Agency (PMDA)
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 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 Kazuhiko Mori

Kazuhiko Mori

Councilor for Pharmaceutical Affairs, Minister’s Secretariat, Ministry of Health, Labour and Welfare (MHLW)
Kazuhiko Mori, MSc., is currently Councilor for Pharmaceutical Affairs, Minister’s Secretariat of the Ministry Health, Lobour and Welfare (MHLW). Mr. Mori has led many of MHLW/PMDA’s drug initiatives. He contributed to introduce new approaches to drug safety regulation including... Read More →
avatar for Nobumasa Nakashima

Nobumasa Nakashima

Associate Executive Director for International Programs and Asia Training Centre, Pharmaceuticals and Medical Devices Agency (PMDA)
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 →


Tuesday June 25, 2019 10:30am - 11:30am
Room 6E San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA