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 NCGMDr. Kondo, Chief Executive of PMDA Dr. Kokudo, President of NCGM
Lecture session Group Photo of HBD members
Lecture session Group Photo of HBD members
Presentation Materials
| Presenter | Theme | |
|---|---|---|
| Introduction | ||
| Mitchell Krucoff Chair, HBD |
Introduction | |
| Keynote Speeches | ||
| Toshiyoshi Tominaga Associate Executive Director, PMDA |
What Makes HBD So Unique and Significant? | |
| Kazuaki Sekiguchi Chair, JFMDA HBD Sub-committee |
Clinical Investigations in Japan then and now | |
| Neal Fearnot Vice President, Cook Group Inc. |
Changes Brought About by HBD and Future Direction | |
| Session1: Update of HBD Activities | ||
| Christopher Volker Cardiovascular Systems, Inc. |
Orbital Atherectomy for Calcific Coronary Lesions | |
| Stephen M. Rowland OrbusNeich Medical, Inc. |
Coronary Stent Innovation: EPC Capture | |
| Noah Bartsch TVA Medical, Inc. |
Endovascular AV Fistula | |
| Satoshi Yasukochi Nagano Children’s Hospital |
HBD for Children: Progress and Challenges | |
| Session 2: Real World Evidence | ||
| Danica Marinac-Dabic CDRH, U.S. FDA |
National and International Efforts for Developing Real World Evidence | |
| Kazuhiro Sase Juntendo University |
View from Japanese Academia | |
| Akihide Konishi PMDA |
Challenges and Efforts; PMDA’s View | |
| Misti Malone CDRH, U.S. FDA |
Use Experience of Real World Evidence in the Actual Review | |
| Andy Crosbie MHRA |
Use of Real World Evidence under MDR | |
| Neal Fearnot
Cook Group, Inc.
|
Expectation from Medical Device Industry | |
| Session 3: Early Feasibility Study | ||
| Shigeru Saito Shonan Kamakura General Hospital |
Expectation from Japanese Physician | |
| Robert Thatcher 4C Medical Technologies, Inc. |
Challenges in Development of Innovative Device | |
| Yumiko Aoyagi MHLW |
Regulations on Clinical Studies in Japan | |
| Ken Cavanaugh CDRH, U.S. FDA |
FDA Considerations for Initiating EFS | |
| Ken Kozuma Teikyo University Hospital |
Experience of First in Human Study in Japan | |
| Round Table Discussion: Let’s Join Forces to Overcome the Challenges in Medical Device Clinical Trials! | ||
| Seigo Nakano Terumo Corporation, Japan |
Issues Brought Up by Japanese Medical Device Industry | |