JSPCCS-AHA Joint Symposium

JSPCCS-AHA Joint Symposium （I-AHAJS）
HBD-children in JAPAN

Thu. Jul 5, 2018 8:40 AM - 11:50 AM 第2会場 (301)

座長:安河内聰（長野県立こども病院循環器小児科）
座長:Nicole G. Ibrahim（U.S. Food and Drug Administration, USA）

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[I-AHAJS-Session01] What We Can Do Now to Foward Development of Pediatric Medical Device?

[I-AHAJS-01] Introduction of HBD-children

^○杉山央 (東京女子医科大学心臓病センター循環器小児科)

[I-AHAJS-02] Activity in US

^○Nicole G. Ibrahim (U.S. Food and Drug Administration, USA)

[I-AHAJS-03] Activity in Japan

^○田中大祐 (厚生労働省医薬・生活衛生局)

[I-AHAJS-04] Request to the regulatory from the industry

^○日本ライフライン株式会社

[I-AHAJS-Discussion01] Importance of international harmonization
How to use existing data to facilitate development
Incentive to motivate industries

高橋彩来¹, Richard Ringel², Frank Ing³, 杉山央⁴, Nicole G. Ibrahim⁵, 田中大祐⁶, 日本ライフライン株式会社 (1.医薬品医療機器総合機構, 2.Johns Hopkins Hospital, USA, 3.Los Angeles Children’s Hospital, USA, 4.東京女子医科大学心臓病センター循環器小児科, 5.U.S. Food and Drug Administration, USA, 6.厚生労働省医薬・生活衛生局)

[I-AHAJS-Session02] Clinical Evaluation to Develop Pediatric Medical Device

[I-AHAJS-05] Coarctation Of the Aorta Stent Trials: What can we learn from the COAST/COAST II studies?

^○Richard Ringel (Johns Hopkins School of Medicine)

[I-AHAJS-06] Clinical evaluation of Genesis XD stent for PMA approval

^○Frank Ing (Los Angeles Children's Hospital, USA)

[I-AHAJS-07] Doctor oriented clinical trial of CP stent for pulmonary stenosis

^○富田英 (昭和大学病院　小児循環器・成人先天性心疾患センター)

[I-AHAJS-08] Clinical Evaluation for Approval of Pediatric Medical Devices; from Regulatory Stand of View

^○中村泰子 (医薬品医療機器総合機構)

[I-AHAJS-09] Clinical Evaluation for Approval of Pediatric Medical Devices; from Regulatory Stand of View

^○TBA

[I-AHAJS-Discussion02] Pre- and post-market clinical evaluation of pediatric medical devices, special focus on its feasibility
How to set and how to evaluate the primary and the secondary end point to develop these devices ?

杉山央¹, 日本ライフライン株式会社, 方眞美², Richard Ringel³, Frank Ing⁴, 富田英⁵, 中村泰子⁶ (1.東京女子医科大学心臓病センター循環器小児科, 2.医薬品医療機器総合機構, 3.Johns Hopkins School of Medicine, 4.Los Angeles Children's Hospital, USA, 5.昭和大学病院　小児循環器・成人先天性心疾患センター, 6.医薬品医療機器総合機構)

Session information

JSPCCS-AHA Joint Symposium （I-AHAJS）
HBD-children in JAPAN

[I-AHAJS-Session01] What We Can Do Now to Foward Development of Pediatric Medical Device?

[I-AHAJS-01] Introduction of HBD-children

[I-AHAJS-02] Activity in US

[I-AHAJS-03] Activity in Japan

[I-AHAJS-04] Request to the regulatory from the industry

[I-AHAJS-Discussion01] Importance of international harmonization
How to use existing data to facilitate development
Incentive to motivate industries

[I-AHAJS-Session02] Clinical Evaluation to Develop Pediatric Medical Device

[I-AHAJS-05] Coarctation Of the Aorta Stent Trials: What can we learn from the COAST/COAST II studies?

[I-AHAJS-06] Clinical evaluation of Genesis XD stent for PMA approval

[I-AHAJS-07] Doctor oriented clinical trial of CP stent for pulmonary stenosis

[I-AHAJS-08] Clinical Evaluation for Approval of Pediatric Medical Devices; from Regulatory Stand of View

[I-AHAJS-09] Clinical Evaluation for Approval of Pediatric Medical Devices; from Regulatory Stand of View

[I-AHAJS-Discussion02] Pre- and post-market clinical evaluation of pediatric medical devices, special focus on its feasibility
How to set and how to evaluate the primary and the secondary end point to develop these devices ?

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Session information

JSPCCS-AHA Joint Symposium （I-AHAJS）HBD-children in JAPAN

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JSPCCS-AHA Joint Symposium （I-AHAJS）
HBD-children in JAPAN