Innovation
FDA Japan
Session Two [Non-CME]
Kenneth Cavanaugh, Jr., PhD
Deputy Director, Office of Cardiovascular Devices
U.S. Food and Drug Administration
Silver Spring, Maryland, United States
Neal Fearnot, PhD
Vice President
Cook Group Incorporated
West Lafayette, Indiana, United States
Speaker: Shigeru Saito, MD, FACC, FSCAI – Shonan Kamakura General Hospital
Speaker: Madoka Murakami, PhD – Pharmaceuticals and Medical Devices Agency
Moderator: Stephen Browning, BSE – FDA/CDRH
Moderator: Madoka Murakami, PhD – Pharmaceuticals and Medical Devices Agency
Speaker: Stephen Browning, BSE – FDA/CDRH
Speaker: Cassie A. Scherer, JD – Medtronic
Speaker: Fumiaki Ikeno, MD – Stanford University
Panel Moderator: Stephen Browning, BSE – FDA/CDRH
Panel Moderator: Madoka Murakami, PhD – Pharmaceuticals and Medical Devices Agency
Panel Discussant: Cassie A. Scherer, JD – Medtronic
Speaker: Hiren Mistry, MSE – Food and Drug Administration
Moderator: Misti Malone, PhD – FDA
Moderator: Hiroyoshi Yokoi, MD – Fukuoka Sanno Hospital
Speaker: Marika Doi, PhD – Pharmaceuticals and Medical Devices Agency (PMDA)
Speaker: Hiroyoshi Yokoi, MD – Fukuoka Sanno Hospital
Speaker: Leisa Martinez – Medtronic
Speaker: Helen Reeve-Stoffer, PhD – Recor Medical Inc
Panel Moderator: Misti Malone, PhD – FDA
Panel Moderator: Hiroyoshi Yokoi, MD – Fukuoka Sanno Hospital
Panel Discussant: Marika Doi, PhD – Pharmaceuticals and Medical Devices Agency (PMDA)
Panel Discussant: Leisa Martinez – Medtronic
Panel Discussant: Hiren Mistry, MSE – Food and Drug Administration
Panel Discussant: Helen Reeve-Stoffer, PhD – Recor Medical Inc
Speaker: Neal E. Fearnot, PhD – Cook Group Incorporated
Moderator: Mitchell Krucoff, MD, FACC – Duke University Medical Center/Duke Clinical Research Institute
Moderator: Shigeru Saito, MD, FACC, FSCAI – Shonan Kamakura General Hospital
Speaker: Shigeru Saito, MD, FACC, FSCAI – Shonan Kamakura General Hospital
Speaker: Katherine Kumar, PhD, RAC – 4C Medical Technologies, Inc.
Speaker: Declan Dineen, BSc, MSc – Medtronic Inc.
Speaker: Stephen M. Rowland, PhD – OrbusNeich Medical Inc.
Speaker: Robert Thatcher, MBA – Diaxamed, LLC
Panel Moderator: Mitchell Krucoff, MD, FACC – Duke University Medical Center/Duke Clinical Research Institute
Panel Moderator: Shigeru Saito, MD, FACC, FSCAI – Shonan Kamakura General Hospital
Panel Discussant: Declan Dineen, BSc, MSc – Medtronic Inc.
Panel Discussant: Marika Doi, PhD – Pharmaceuticals and Medical Devices Agency (PMDA)
Panel Discussant: Neal E. Fearnot, PhD – Cook Group Incorporated
Panel Discussant: Nicole Ibrahim, PhD – U.S. Food and Drug Administration
Panel Discussant: Katherine Kumar, PhD, RAC – 4C Medical Technologies, Inc.
Panel Discussant: Stephen M. Rowland, PhD – OrbusNeich Medical Inc.
Panel Discussant: Robert Thatcher, MBA – Diaxamed, LLC
Speaker: Mitchell Krucoff, MD, FACC – Duke University Medical Center/Duke Clinical Research Institute