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HBD East 2013 material


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