FDA Japan | Session One [Non-CME]

Sunday, March 10, 2024

8:00 AM – 11:40 AM ET

Program Director(s)

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

Disclosure(s):

Kenneth J. Cavanaugh, PhD, Jr.: No financial relationships to disclose

Neal E. Fearnot, PhD: Cook Medical: Employee (Ongoing)

Presentations:

8:00 AM – 8:15 AM ET

Introduction to Harmonization by Doing: 20 Years of Achievements
Speaker: Mitchell Krucoff, MD, FACC – Duke University Medical Center/Duke Clinical Research Institute
8:00 AM – 8:50 AM ET

PLENARY SESSION: CURRENT AND FUTURE US-JAPANESE COLLABORATIONS
Moderator: Neal E. Fearnot, PhD – Cook Group Incorporated
Moderator: Shohei Kurosawa – Ministry of Health, Labour and Welfare
8:15 AM – 8:30 AM ET

CDRH International Update
Speaker: Kenneth J. Cavanaugh, Jr., PhD – U.S. Food and Drug Administration
8:30 AM – 8:50 AM ET

Update on Japanese Medical Device Regulatory Initiatives
Speaker: Shohei Kurosawa – Ministry of Health, Labour and Welfare
8:50 AM – 9:00 AM ET

Update on HBD for Children Activities
Speaker: Wakako Sakamoto, PhD – Office of Medical Device I, Pharmaceuticals and Medical Device Agency (PMDA)
8:50 AM – 10:00 AM ET

HBD FOR CHILDREN – GLOBAL PEDIATRIC DEVICE DEVELOPMENT
Moderator: Nicole Gillette – FDA
Moderator: Sung-Hae Kim, MD – Shizuoka Children's Hospital
9:00 AM – 9:10 AM ET

POC Project update – Renata Medical
Speaker: Evan Zahn, MD – Cedars-Sinai Medical Center
9:10 AM – 9:20 AM ET

Update on Academic Research Consortium (ARC) Efforts
Speaker: Takanari Fujii, MD, phD – Pediatric Heart Disease and Adult Congenital Heart Disease Center, Showa University Hospital
9:20 AM – 9:30 AM ET

Regulatory Advances in Pediatric Device Availability
Speaker: Emily Olszewski, PhD – Food and Drug Administration
9:30 AM – 10:00 AM ET

Panel Discussion
Panel Moderator: Nicole Gillette – FDA
Panel Moderator: Sung-Hae Kim, MD – Shizuoka Children's Hospital
Panel Discussant: Takanari Fujii, MD, phD – Pediatric Heart Disease and Adult Congenital Heart Disease Center, Showa University Hospital
Panel Discussant: Emily Olszewski, PhD – Food and Drug Administration
Panel Discussant: Wakako Sakamoto, PhD – Office of Medical Device I, Pharmaceuticals and Medical Device Agency (PMDA)
Panel Discussant: Evan Zahn, MD – Cedars-Sinai Medical Center
10:00 AM – 10:15 AM ET

BREAK
10:15 AM – 10:30 AM ET

Japanese Perspective on Global Medical Device Ecosystem
Speaker: Takahiro Uchida, MD, MSc – Sanamedi, Inc.
10:15 AM – 11:30 AM ET

GLOBAL DEVICE DEVELOPMENT: LESSONS LEARNED
Moderator: Eric A. Chen, MS – Abbott
10:30 AM – 10:45 AM ET

Start-up Environment in Japan: Has It Changed?
Speaker: Fumiaki Ikeno, MD – Stanford University
10:45 AM – 11:00 AM ET

Medical Device Business Considerations in Japan
Speaker: Kazuhisa Senshu, PhD – Terumo Corporation
11:00 AM – 11:30 AM ET

Panel Discussion
Panel Moderator: Eric A. Chen, MS – Abbott
Panel Discussant: Kenneth J. Cavanaugh, Jr., PhD – U.S. Food and Drug Administration
Panel Discussant: Marika Doi, PhD – Pharmaceuticals and Medical Devices Agency (PMDA)
Panel Discussant: Shohei Kurosawa – Ministry of Health, Labour and Welfare
Panel Discussant: Kazuhisa Senshu, PhD – Terumo Corporation
Panel Discussant: Kate Stohlman, MBA, RAC – Corvia Medical, Inc.
Panel Discussant: Takahiro Uchida, MD, MSc – Sanamedi, Inc.
11:30 AM – 11:40 AM ET

Closing Remarks
Speaker: Neal E. Fearnot, PhD – Cook Group Incorporated
11:40 AM ET

Adjourn