Through Japan-US Medical Device Harmonization by Doing (HBD), the U.S. FDA, 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 2019 Think Tank Meeting will be held on December 11, 2019 in Tokyo.
In this meeting, recent hot topics such as utilization of real world evidence and promotion of development of medical devices for children will be discussed in addition to providing working group activity updates. In panel discussion, experts from government, academia and industry in Japan and the U.S. will share their experiences and discuss potential solutions for overcoming shared challenges in the development of medical devices.
This meeting is open to public. We look forward to having many stakeholders for productive discussion.
Ministry of Health, Labour and Welfare (MHLW)
Pharmaceuticals and Medical Devices Agency (PMDA)
The Japan Federation of Medical Device Associations (JFMDA)
Wednesday, December 11, 2019
9:30 a.m. - 5:30 p.m.
Nadao Hall, Zenshakyo
Shin-Kasumigaseki Building lobby floor, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo, Japan
Please click here for information.
*Simultaneous interpretation (English - Japanese) provided
Please visit the website below for registration.
Registration will be closed once the number of applicants reaches full capacity.
Please contact to below email if you have any questions on HBD East 2019.
HBD East 2019 Secretatiat
Email : global*jfmda.gr.jp (Please replace * to @)