PMDA’s Recent Challenges - Regulatory Science and Innovation

Date: Thursday,  October 18, 2018
Time: 12:00 - 14:00
Venue: Tokyo American Club, 
Brooklyn Room
Speaker: Dr. Tatsuya Kondo, Chief Executive, Pharmaceuticals and 
Medical Devices Agency (PMDA)
Hosting Committees: 
Healthcare, Digital Health, 
​Medical Devices and Diagnostics, 
Pharmaceuticals, 
Regenerative Medicine and Bioscience
Member Fee: 4,500
Guest Fee: 7,900
Meal: Plated Lunch 
Registration/Cancellation Deadline: Monday, October 15, 
​12:00 noon

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In recent years, Japan's Pharmaceuticals and Medical Devices Agency (PMDA) has taken several steps towards innovating the regulatory process to deliver safer and more effective medicines and devices to patients. Dr.Tatsuya Kondo, Chief Executive of PMDA will provide a comprehensive presentation on the PMDA's recent challenges.

PMDA has implemented various innovative regulatory initiatives including SAKIGAKE Designation System, Conditional Early Approval System for Pharmaceuticals and MID-NET project. And most recently, PMDA has established Regulatory Science Center which is the command center of PMDA’s Regulatory Science. PMDA also gives high priority on international cooperation and continue its efforts for patients in the world together with other regulatory authorities.

Dr. Kondo's presentation promises to provide healthcare company representatives with a rare opportunity not only to learn about the future course of regulatory reviews and approvals in Japan, but also to directly converse with one of Japan's key healthcare leaders on Japan's plans for its healthcare industry. If your business is in healthcare or related to the healthcare industry, you will not want to miss this unique opportunity.

John W. Carlson III, Chair
William Bishop, Andrew Joyce, Yuko Kidoguchi, Takeo Morooka, Toshio Nagase,
R. Byron Sigel, Mika Shirai, Vice Chairs
ACCJ Healthcare Committee

Eiji Sasahara, Chair
Seiji Inada, Marc Fuoti, Vice Chairs
ACCJ Digital Health Subcommittee 

William Bishop, Chair
Marie Kissel, Yasuhiko Amano, Jun Sekiguchi, Vice Chairs
ACCJ Medical Devices and Diagnostics Subcommittee

Takeo Morooka, Chair
ACCJ Pharmaceuticals Subcommittee

Yaju Hiromichi, Chair
Satoshi Tanaka, Vice Chair
ACCJ Regenerative Medicine and Bioscience Subcommittee

NOTE 1: This event is ON THE RECORD.

NOTE 2: If you cancel after the stated deadline, the full meeting fee will be charged to your account. All guests must be accompanied by an ACCJ member. Sorry, no substitutions or walk-ins.

​NOTE 3: If you are driving to the Tokyo American Club, please inform the ACCJ of the make, model, color and plate of the vehicle, by the registration deadline, as arrangements must be made. A 1,700 yen parking fee will apply.