Committee Panel Discussion

Committee Panel Discussion 1

Thu. Jul 11, 2024 9:40 AM - 11:30 AM 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）

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

^○Nicole Gillette (The US Food and Drug Administration)

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

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

[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)

[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)

[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)

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

^○Shin Iwamoto (Pharmaceuticals and Medical Devices Agency (PMDA))

Session information