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Presentations of HBD East 2013 Think Tank Meeting
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| Title & Presenter | |
|---|---|
| Tuesday, July 9th , 2013 – Yayoi Memorial Hall | |
| 8:30 | Registration |
| Opening Remarks | |
| 9:30 - | Atsushi Tamura, HBD co-chair |
| Welcome Speech | |
| 9:35 - | Shigekazu Komoto |
| Keynote Speech | |
| 9:40 - | Shigeru Saito |
| Update from Working Group4 | |
| 9:50 - | Introduction and Progress Kentaro Azuma |
| 10:00 - | GCP Update and Next Steps Neal Fearnot and Kazuo Yano |
| 10:10 - | Comparative Analysis of Japan and US Data Reliability Assessment Chie Iwaishi and Kazuo Tomida |
| 10:20 - | Summary Technical Documentation (STED) “Harmonizing a Predictable Regulatory Submission” Donna Haire |
| 10:30 - | Orphan Device Comparison Yuka Suzuki and Neal Fearnot |
| 10:40 - | Panel Discussion -What is different in practice as a result of the work of WG 4?- Moderators: Kentaro Azuma, Neal Fearnot Panelists: Kazuo Yano, Chie Iwaishi, Donna Haire, Yuka Suzuki, Koji Ikeda, Kazuo Tomida, Jennifer Kerr |
| 11:00 - | Coffee Break |
| Update from Working Group 2 | |
| 11:15 - | J-MACS Takeshi Nakatani |
| 11:30 - | New Direction of WG2 Masayuki Kawahara |
| 11:40 - | Panel Discussion Moderator: Kazuhiro Sase Panelist: Takeshi Nakatani, Koji Todaka, Masayuki Kawahara, |
| Scientific Session 1 | |
| Valvular Heart Disease in Japan-USA Moderators: Kazuhiro Sase |
|
| 11:55- | Experience of PI in Japan
Yoshiki Sawa |
| 12:10- | TAVI in the next generation Bernard Lyons |
| 12:25- | Panel discussion Panelists: Bernard Lyons, Mitchell Krucoff, Yoshiki Sawa, Haruki Shirato, Gary Thompson, Shigeru Saito |
| 12:45 - | Lunch |
| Update from Working Group 3 | |
| 14:00 - | Clinical Trial Cost Survey Results in Japan - Lessons learned from Cost Survey Izumi Fukuzawa |
| 14:10 - | Infrastructure of Translational Research for medical devices in Japan Yoshihiro Arakawa |
| 14:20 - | Panel discussion Moderator: Yoshihiro Arakawa Panelists: Makoto Akabori, Neal Fearnot, Izumi Fukuzawa Allison Handler, Takahiro Uchida |
| Update from Working Group 1 | |
| 14:30 - | Educational Program by HBD WG1 Gary Thompson |
| 14:40 - | Overview of POC project Hiroyoshi Yokoi |
| 14:50 | Overview of WG1 activity Shin Iwamoto |
| 15:00 - | Panel Discussion Moderators: Gary Thompson, Hiroyoshi Yokoi Panelists: Mitchell Krucoff, Takahiro Uchida, Shigeru Saito, Neal Fearnot, Koji Ikeda, Shin Iwamoto |
| 15:15 - | Coffee Break |
| Scientific Session 2 | |
| New Coronary Frontiers and Peripheral Intervention in Japan-USA Moderator: Shigeru Saito, Gary Thompson |
|
| Topic: New medical devices | |
| 15:30- | Combo Stent Steve Rowland |
| 15:40- | OrbitaI Atherectomy and the Understudied Calcified Coronary Lesion Patient Population Robert Thatcher |
| 15:50- | Experience of BVS in Japan Shigeru Saito |
| Topic: Critical Limb Ischemia (CLI) | |
| 16:00- | Guidance on the Evaluation of medical devices for CLI treatment in Japan Hiroyoshi Yokoi |
| 16:10- | Regulatory View of Japan-USA Similarities & Differences Kenneth Cavanaugh (Pre-recorded) |
| 16:20- | Peripheral Academic Research Consortium (PARC) Meeting Mitchell Krucoff |
| Topic: Collaborative Scheme | |
| 16:30- | Overview of collaborative scheme Mami Ho |
| 16:40- | Zilver DES and PAD: Japan-USA Clinical Data & Lessons Learned Neal Fearnot |
| 16:50- | MISAGO
Seigo Nakano |
| 17:00- | Panel discussion Panelists: Shigeru Saito，Mami Ho，Hiroyoshi Yokoi, Seigo Nakano, Steve Rowland, Robert Thatcher, Takahiro Uchida, Kentaro Azuma, Neal Fearnot |
| Medical Device Development during the Past Decade | |
| 17:25 - | Akira Matsumoto, Chairman of the Board, Calbee. Inc |
| 17:35 - | Adjourn |
| Wednesday, July 10th, 2013 – Yayoi Memorial Hall | |
| 8:30 - | Registration |
| Overview of Day1 and preview of Day2 | |
| 9:00 - | Shigetaka Miura |
| Regulators' perspectives for future collaboration between Japan & US | |
| 9:10 - | Jeffrey Shuren, Director, FDA CDRH (Pre-recorded) |
| 9:20 - | Tatsuya Kondo, Chief Executive, PMDA |
| Industry’s perspective for future collaboration between Japan & US | |
| 9:35 - | Koji Nakao, Chair, JFMDA |
| International Collaboration | |
| 9:50 - | Past Decade Mitchell Krucoff |
| 10:00 - | Current Chie Iwaishi |
| 10:10 - | Tomorrow Janet Trunzo |
| 10:20 - | Coffee Break |
| Total Product Life Cycle Management | |
| 10:40 - | Overview and recent efforts in the US Kimberly Trautman |
| 10:55 - | Overview of Japanese Electronic Medical Records Hideto Yokoi |
| 11:10 - | Participation in Post-Market Management of Academia Kazuhiro Sase |
| 11:25 - | Post-Market Surveillance in Japan Tomiko Tawaragi |
| 11:40 - | Panel Discussion Moderators: Mitchell Krucoff, Atsushi Tamura Panelists: Hideto Yokoi, Kimberly Trautman, Kazuhiro Sase, Gary Thompson, Janet Trunzo, Chie Iwaishi, Tomiko Tawaragi |
| Closing Remarks | |
| 12:05 - | Mitchell Krucoff, HBD Co-Chair |
