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

 

Presentations of HBD East 2008 Think Tank Meeting

Summary of HBD East 2008 Think tank Meeting

- Click underlined title then open PDF file in another window.
- Password required
- enter “hbdeast” as a password

	Title	Presenter
7/22 : am ① 9:30-10:10	Welcome remarks 1	Ryozo Nagai(Head of HBD East Planning Committee)
	Welcome remarks 2	Mitchell Krucoff (DCRI)
	Welcome remarks 3	Toshiro Nakagaki(MHLW)
	Welcome remarks 4	Daniel Schultz(FDA/CDRH)
	Welcome remarks 5	Kotaro Fukuda(JFMDA)
	Welcome remarks 6	Michael Gropp(Medtronic)
7/22 : am② 10:10-10:40	HBD principle and structure	Daniel Schultz(FDA/CDRH)
	HBD achievements and perspective (2003-2008)	Mitchell Krucoff (DCRI)
	MHLW perspective on global harmonization	Hiroshi Yaginuma(MHLW)
7/22 : am③ 10:40-11:40	Concept of POC	Toshiyoshi Tominaga(MHLW)
	Regulatory roadmap＜Draft＞	Carole Carey(FDA)
	Industry view	Michael Gropp(Medtronic)
	Industry view	Gary Thompson(Abbott)
	Industry view	Shigetaka Miura(JFMDA)
7/22 : pm ① 13:00-14:50	WG1	Shigeru Saito(Shonan Kamakura General Hospital)、Mitchell Krucoff (DCRI)
	WG1 Overview and Mission of Harmonized Global Trials	Erica Takai(FDA)
	Potential Timeline Impact of Global POC Studies Using Roadmap	Koji Ikeda(PMDA)
	Participation in Japan-USA Endeavor and Spirit studies--a Principal Investigator's View	Shigeru Saito(Shonan Kamakura General Hospital)
	Challenges for Single Study DES Protocols-Industry view	Gary Thompson(Abbott)
	Lessons Learned from Global Drug Studies-MHLW/PMDA View	Kaori Shinagawa(PMDA)
	Applying Roadmap to Existing POC Programs	Michael Gropp(Medtronic)
	Non-DES Studies	Neal Fearnot(COOK)
	Use of POC Projects Toward the Future Development and Improvement of Single Protocol Trials	Ashley Boam(FDA)
	Post-Market Issues	Yuka Suzuki(PMDA)
7/22 : pm ② 15:10-16:50	WG2 overview	Kazuhiro Sase(Juntendo University)
	Case study	Toshimasa Tokuno(JFMDA)
	Short History of Mechanical Circulatory Support Devices and its advanced technologies	Takeshi Nakatani(NCVC)
	INTERMACS program	Erica Takai(FDA)
	PMDA perspective for introduction of registry system in Japan	Uichiro Kimura(PMDA)
	Drug Device Interaction 2008	Mitchell Krucoff (DCRI)
7/23 : am ① 9:20-10:50	Overview - Deliverables and Priorities	John Alexander(DCRI)
	The Past - Challenges for devices clinical trials infrastructure in the US and Japan -Japanese perspective	Shuichi Takayama(JFMDA)
	The Past - Challenges for devices clinical trials infrastructure in the US and Japan -US perspective	Neal Fearnot(COOK )
	The Future - Changes to the research infrastructure in Japan -Japan Clinical Research 5 year plan	Hideo Kusuoka(Osaka Medeical Center)
	The Future - Changes to the research infrastructure in Japan -One success story: The UHCT Alliance Experience	Yoshihiro Arakawa(Hospital of Tokyo University)
	Are there sufficient numbers of Japanese sites and investigators: Role of Japanese professional societies	Takaaki Isshiki(Teikyo University)
	What makes a good site: site / investigator metrics	Allison Handler(DCRI)
	Moving from Talking to Doing: Potential POC project design	John Alexander(DCRI)
7/23 : am② 11:00-12:30	WG4 overview	Hiroshi Yaginuma(MHLW)
	Comparison of GCP between the USA and Japan Report on progress	Neal Fearnot(COOK) , Yoshihiro Noda(JFMDA)
	STED comparison Report on progress	Hiroshi Ishikawa(JFMDA),Donna Haire(Philips)
	Pre-IDE/pre-submission consultations Role of regulatory authorities in device development process	Martin Yahiro (Medtronic)
	Pre-IDE/pre-submission consultations JFMDA view	Tooru Aoki (JFMDA)
	FDA view	Carole Carey (FDA)
	PMDA perspective on its consultation system	Yuka Suzuki（PMDA）