Session Details

Committee Panel Discussion 1

Thu. Jul 11, 2024 9:40 AM - 11:30 AM JST
Thu. Jul 11, 2024 12:40 AM - 2:30 AM UTC
ROOM 4 (4F 411+412)
Chair:Kensuke Ishii(Pharmaceuticals and Medical Devices Agency, Tokyo)
Chair:Shintaro Nemoto(Osaka Medical and Pharmaceutical University, Osaka)
Commentator:Hiroyuki Yamagishi(Tokyo Metropolitan Children's Hospital, Tokyo)
Commentator:Sung-Hae Kim(Department of Cardiology, Shizuoka Children's Hospital, Shizuoka)

[I-CPD1-1]Innovation for Pediatric Cardiology – FDA Perspective

Nicole Gillette (The US Food and Drug Administration)
Comment()

[I-CPD1-2]The vision of HBD for Children activities

Wakako Sakamoto (Pharmaceuticals and Medical Devices Agency (PMDA), Tokyo)
Comment()

[I-CPD1-3]Introduction of Stents for Congenital Heart Disease through Japan-U.S. Collaboration of Industry, Regulatory, and Academia

Takanari Fujii (Pediatric Heart Disease and Adult Congenital Heart Disease Center, Showa University Hospital, Tokyo)
Comment()

[I-CPD1-4]Joint Japan-U.S. industry-government-academia treatment evaluation item formulation -ARC-MCS

Yasutaka Hirata (Department of Cardiac Surgery, The University of Tokyo Hospital, Tokyo)
Comment()

[I-CPD1-5]The challenge of developing pediatric medical devices which commercialization is difficult to predict -Use of support from academia and government-

Kentaro Fujinaga (Implantable Medical Device Development Department, Regenerative Medicine & Implantable Medical Device Division, Teijin Limited, Tokyo)
Comment()

[I-CPD1-6]The Japanese reimbursement system of pediatric medical devices

Shin Iwamoto (Pharmaceuticals and Medical Devices Agency (PMDA))
Comment()