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Tuesday, June 27 • 4:00pm - 5:00pm
#275: PMDA Town Hall

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-23-600-L04-P; CME 1.00; RN 1.00

PMDA is implementing new regulations to promote regulatory sciences and accelerate product developments based on “4Fs”, the priorities. In this session, PMDA will share the latest details regarding its policies and initiatives.

Learning Objectives

Recognize latest information on the Pharmaceuticals and Medical Devices Agency’s activity and Japanese regulations in medical products area; Discuss issues on medical products regulation with senior PMDA officials.

Chair

Junko Sato, PhD

Speaker

Toward Accelerating Patient Access
Shinobu Uzu, PhD

Regulatory Collaboration in Asia
Daisuke Koga, MSc, RPh

Regulatory Update from the MHLW
Mao Yanagisawa, MPH


Speakers
avatar for Junko Sato

Junko Sato

Associate Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Sato joined the Pharmaceuticals and Medical Devices Agency (PMDA) in 1998, and she is currently the Associate Executive Director. She has work experiences in new drug review for 11 yrs, risk management for 3 yrs, and international area for 11 yrs. She also worked in U.S. FDA as... Read More →
avatar for Mao Yanagisawa

Mao Yanagisawa

Deputy Director, Office of International Regulatory Affairs, Ministry of Health, Labour and Welfare (MHLW), Japan
Ms. Mao Yanagisawa is Deputy Director, Office of International Regulatory Affairs for the Pharmaceutical Safety and Environmental Health Bureau at Ministry of Health, Labour and Welfare (MHLW). She is responsible for coordinating on pharmaceutical regulatory harmonizing activities... Read More →
avatar for Daisuke Koga

Daisuke Koga

Ministry of Health, Labour and Welfare (MHLW)
avatar for Shinobu Uzu

Shinobu Uzu

Senior Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Mr. Shinobu Uzu is senior Executive Director, PMDA since April 2020. As Chief Safety Officer, PMDA, he was responsible for post-market surveillance and GMP/QMS audit of pharmaceuticals, medical devices regulated by Pharmaceuticals and Medical Devices Law until March 2018. Mr. Uzu... Read More →

Tuesday June 27, 2023 4:00pm - 5:00pm EDT
Room 153 AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  09: Regulatory, Session