HBD is an international effort to develop global clinical trials and address regulatory barriers that may be impediments to timely device approvals.

Japan-US HBD East 2008 Think Tank Meeting
July 22-23, 2008 (Tokyo, Japan)

The 2nd HBD (Harmonization By Doing) Think Tank Meeting will convene on July 22-23, 2008 at the National Olympics Memorial Youth Center in Tokyo, Japan. This meeting provides a forum for discussion on convergence of regulatory requirements and practices through concrete experience “by doing” in the US and Japan. It will discuss the progress of the ongoing activities in all four working groups as well as forward and future direction of HBD:
(http://www.fda.gov/cdrh/international/hbdpilot.html)

• WG1 - Global Cardiovascular Device Trials
• WG2 - Postmarket Registries ( e.g., artificial heart)
• WG3 - Clinical Trials Infrastructure and Methodology
• WG4 - Regulatory Convergence and Communication

Who should attend?

Medical device regulators, medical practitioners, industry professionals, students and professors in medical technology and regulatory affairs interested in learning about the HBD activities and its efforts for convergence of regulatory requirements and practices.

Date

July 22-23, 2008

Venue

National Olympics Memorial Youth Center
3-1, Yoyogi Kamizono-cho, Shibuya-ku, Tokyo, Japan 151-0052
TEL. +81-3-3469-2525
For more information: http://nyc.niye.go.jp/e/

Draft Agenda(107k)