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International Activities

HBD East 2023 Think Tank Meeting

Through Japan-US Medical Device Harmonization by Doing (HBD)1, the U.S. FDA2, MHLW/PMDA, academia, and industry developed internationally agreed upon standards for global clinical trials related to cardiovascular devices, and addressed regulatory barriers that may delay timely medical device approvals in both countries.

In order to announce the outcome of recent HBD activities and discuss future plans with the public, the HBD East 2023 Think Tank Meeting will be held on December 14, 2023 in Tokyo.

Ref:
1) HBD Brochure (in English)

2) U.S.-Japan Regulatory Collaboration | FDA

Host

Ministry of Health, Labour and Welfare (MHLW)
Pharmaceuticals and Medical Devices Agency (PMDA)
The Japan Federation of Medical Device Associations (JFMDA)

Event information and Program

For more information on HBD East 2023 Think Tank Meeting, please click here.

Date

Thursday, December 14, 2023
9:30 a.m. - 6:00 p.m.

Venue

Ariake Central Tower and Conference (Tokyo)

Registration

Registration fee : Free
Registration system (Registration closed)

Program

Session A:Welcome Speeches
(9:30~)

Session B:20th Anniversary Keynote Speeches
(10:00~)

B-1 HBD history
B-2 Achievements of HBD activities and future expectations

Session C:Learning from HBD activity and recent update
(10:50~)

C-1 Update on HBD activities - Focusing on the last 5 years -
C-2 What we can say now based on our experience in obtaining approval in Japan and the U.S.
Case 1: Japanese industry’s view
C-3 What we can say now based on our experience in obtaining approval in Japan and the U.S.
Case 2: U.S. industry’s view
C-4 Role of Academia in HBD Activities

Session D:Evaluating the efficacy and safety of medical devices from pre-market through
post-market using RWD
(11:40~)

D-1 Basic Approach in utilizing RWD for regulatory decision-making
D-2 Challenges in establishing RWE for pre- and post-market clinical evaluation
D-3 Challenges in developing devices using RWD in Japan

Session E:Approaches of HBD activity to promote the development of SaMD
(13:40~)

E-1 Regulation of SaMD in the U.S.
E-2 Regulation of SaMD in Japan
E-3 Learning from “CureApp” :how to develop and get an approval of SaMD
E-4 Points to consider in the application of AI for medical devices

Session F:Approaches of HBD activity to promote the development of pediatric devices
(14:45~)

F-1 Progress and challenges in pediatric medical device development
F-2 U.S. Regulatory initiatives to promote pediatric medical device development
F-3 The road from development to approval of pediatric medical devices and future approaches
F-4 Utilization of RWD in pediatric medical device development

Session G:What should be considered for global harmonization of medical device
development through HBD activity ?
(16:10~)

G-1 An overview of the global situation surrounding medical devices
G-2 Current situation of medical device regulations outside of Japan and the U.S.
G-3 Comparing clinical practices or consultation processes in the US vs Japan
G-4 Unique points of medical device development and advantages of global development
G-5 Post-approval hurdles: Differences and strategies between Japanese and the U.S. insurance systems

Session H:Closing Remarks
(17:55~)

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