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 was 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 were discussed in addition to WG activity update. In the Round Table Discussion, HBD members and other experts shared their experiences and had a free discussion to overcome the challenges in medical device clinical trials.
164 participants from many stakeholders joined the meeting and had fruitful discussions towards the U.S. - Japan Medical Device Harmonization.
Host
Ministry of Health, Labour and Welfare (MHLW)
The Japan Federation of Medical Device Associations (JFMDA)
Auspices
Pharmaceuticals and Medical Devices Agency (PMDA)
National Center for Global Health and Medicine (NCGM)
Support
Joint Center for Researchers, Associates and Clinicians (JCRAC)
Date
Thursday, December 7, 2017
Venue
National Center for Global Health and Medicine, Main Conference Room
1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan, Training Center 5F
Access http://www.ncgm.go.jp/access/index.html
Program
Scenes from the meeting
Dr. Kondo, Chief Executive of PMDA Dr. Kokudo, President of NCGM
Lecture session Group Photo of HBD members
Presentation Materials