Speaker: Dr. Yasuhiro Fujiwara, Chief Executive, Japan’s Pharmaceutical and Medical Devices Agency (PMDA)

Hosting Committee: Healthcare

Member Fee: ¥600

Guest Fee: ¥1,200

Registration/Cancellation Deadline: Friday, November 6, Noon


This event will be hosted as a webinar. Instructions for joining the virtual meeting will be sent to registered attendees after the above stated deadline.



Event Overview

When Dr. Yasuhiro Fujiwara took the position of Chief Executive of Japan’s Pharmaceutical and Medical Devices Agency (PMDA) in April 2019, he coined the agency’s “4 Fs” motto, which prioritizes: “patient first, access first, safety first, and Asia first.” Over the past several years, the PMDA has innovated the regulatory process to deliver safer and more effective medicines and devices to patients. With the formalization of the SAKIGAKE Designation System and Conditional Early Approval, and advancements in Information and Communication Technology (ICT), such as the agency’s MID-NET, many are looking to the newest developments in regulatory science to understand what it has to offer patients and the healthcare industry alike. The PMDA is leading the way, driving discussions on such topics as regional regulatory harmonization and the utilization of real-world data (RWD) in regulatory submissions, all while championing its own workstyle reform initiatives.
On November 9, Dr. Fujiwara joins us in a presentation that promises to provide healthcare company representatives a rare opportunity to learn about the future of the PMDA and regulatory excellence in Japan.


John W. Carlson III, Chair
William Bishop, Yuko Kidoguchi, Takeo Morooka, Toshio Nagase, Mika Shirai, Katsunori Fujita, Maya Mamiya, Vice Chairs
ACCJ Healthcare Committee

NOTE 1: This event is OFF THE RECORD.

NOTE 2: Please note that, as with all guest presentations, the content and comments of the speakers reflect their own opinions and do not necessarily represent the opinions or policies of the ACCJ.

NOTE 3: If you cancel after the stated deadline, the full meeting fee will be charged to your account.