Through the U.S. - Japan Medical Device Harmonization by Doing (HBD), the US FDA, Japanese regulators, 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.
HBD East 2017 Think Tank Meeting will be held on December 7, 2017 at the National Center for Global Health and Medicine in Tokyo.
In this meeting, recent hot topics such as Early Feasibility Study and Real World Evidence will be discussed in addition to WG activity update. In the Round Table Discussion, HBD members and other experts will share their experiences and have a free discussion with you to overcome the challenges in medical device clinical trials.
This meeting is open to public. We look forward to having many stakeholders for productive discussion.
Ministry of Health, Labour and Welfare (MHLW)
The Japan Federation of Medical Device Associations (JFMDA)
Pharmaceuticals and Medical Devices Agency (PMDA)
National Center for Global Health and Medicine (NCGM)
Joint Center for Researchers, Associates and Clinicians (JCRAC)
Thursday, December 7, 2017
National Center for Global Health and Medicine, Main Conference Room
1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan, Training Center 5F
Registration is closed (It reached full capacity).
HBD 2017 Secretariat
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