U.S.-Japan Industry-Academia-Government Symposium
for Regulatory Harmonization for Medical Devices

HBD East 2021 Think Tank Meeting

Thursday, January 13th, 2022, 18:00-21:00 (US, EST)

Thursday, January 20th, 2022, 18:00-21:00 (US, EST)

Purpose of the Symposium

Through U.S.-Japan Medical Device Harmonization by Doing (HBD), the U.S. FDA, MHLW/PMDA, academia, and industry have 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.

We would like to have a HBD East 2021 Think Tank Meeting. In this meeting, HBD members from government, academia and industry both in the US and Japan will give lectures and have discussions about current HBD activities as well as the following themes, which have received a lot of attention in recent years;

Main theme of lecture and discussion

report on current HBD activities
utilization of real world evidence
facilitation of development of medical device for children
practical use of the latest medical device approval system
global clinical trials considering patients’ participation
effective review of Software as a Medical Device (SaMD)

General Information

Theme	HBD East 2021 Think Tank Meeting
Host	Ministry of Health, Labour and Welfare (MHLW) Pharmaceuticals and Medical Devices Agency (PMDA) The Japan Federation of Medical Device Associations (JFMDA)
Date	Thursday, January 13th, 2022, 18:00-21:00 (US, EST) Thursday, January 20th, 2022, 18:00-21:00 (US, EST)
Symposium Location	Online (Zoom)
Language	Japanese and English (Translation from Japanese to English, from English to Japanese)
Participation fee	free of charge

Program

Please click here for detailed information