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