Japan-US HBD East 2021 Think Tank Meeting

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HBD(Harmonization By Doing)は、日米における医療機器に関する規制について、実践を通して整合化を図ることを目的とした、日米の官・学・民による共同活動です。2003年から開始され、これまで日米共同治験の実施や、日米同時承認等を実現してきました。

このたび、HBD East 2021 Think Tank Meetingを下記の通り開催し、日米の行政、アカデミア、医療機器産業界から多くの方々にご参加いただきました。本会議ではHBD活動の報告に加え、リアルワールドエビデンスの活用、小児用医療機器の開発促進、プログラム医療機器の効率的な審査など、現在注目されている話題について議論しました。また、各セッションの最後にはパネルディスカッションを行い、産官学で医療機器開発における課題を議論し、解決策を検討しました。

主催

厚生労働省
独立行政法人医薬品医療機器総合機構
一般社団法人日本医療機器産業連合会

会議日程

2022年1月14日(金曜日)8時から11時、2022年1月21日(金曜日)8時から11時

会場

Web開催(Zoom)

プログラム

Day1のプログラムはこちら[601KB]、Day2のプログラムはこちら[544KB]をご覧ください。注:日英同時通訳あり

Day1

8時から8時20分 Welcome Speeches

8時20分から8時40分 Keynote Speeches

Regulatory Innovation for Safe and Early Access to Medical
Devices in Japan
Hidehito SEKINO, MHLW

8時40分から8時50分 Update of HBD Activity

HBD Steering Committee[3.33MB]
Erika NORO, Office of Medical Devices II, PMDA

HBD for Children[470KB]
Kalkidan Molla, CDRH, FDA

8時50分から9時25分 Rethinking of the New Style of Global Clinical Trial <Section1: Clinical Design>

The outlook for Patient Involvement in Medical Device Development ~Japanese Regulatory View~[319KB]
Takeshi SHIBA, Office of Medical Devices I, PMDA

The outlook for Patient Involvement in Medical Device Development ~US Regulatory View~

Michelle Tarver, CDRH, FDA

Panel Discussion

9時25分から10時 Rethinking of the New Style of Global Clinical Trial <Section2: GCP Inspection>

Considerations for GCP inspections of global clinical trials[442KB]
Kazuo KAWAHARA, Boston Scientific

Balancing reliability assurance and optimization GCP inspection based on trends of conducting global clinical trial[485KB]
Takashi YOSHITANI, Office of Standard and Compliance for Medical Devices, PMDA

Panel Discussion

10時から11時 “How to promote the development of pediatric medical devices.”~HBD for children~

Report from Japanese national grant research to promote the efficient development of pediatric medical devices[597KB]
Wakako SAKAMOTO, Office of Medical Devices I, PMDA.

Importance of Global development ~Experience from HBD for children’ s POC, Harmony valve~[915KB]
Declan Dineen, Medtronic

Importance of Global development ~Standardization of definitions~
Shintaro NEMOTO, Osaka Medical and Pharmaceutical University

Panel Discussion

Closing Remarks

Day2

8時から8時5分 Opening remarks

8時5分から9時5分 Initiatives to improve patient access to new medical devices

Introduction and Perspective of new regulatory pathways
~ Japanese regulatory view~[525KB]
Kanako SASAKI, MHLW

Introduction and Perspective of new regulatory pathways
~ US regulatory view~[1.42MB]
Hiren Mistry, CDRH, FDA

Learning from examples of how to utilize a new system for early approval of a new medical device
a. US: Zachary Woodson, LimFlow[562KB]
b. Japan: Edwards SAPIEN3
(Expand indications for transcatheter pulmonary valve replacement)
Aya SAEKI, Edwards

Panel Discussion

9時5分から10時5分 “Sustainable Development Goals in Real-world data collection”

How to ensure the reliability of registry data~Experience from PMA approval with registry data~[417KB]
Misti Malone, CDRH, FDA

Introduce the Japanese guidance “To ensure reliability when using registry data for approval applications”[2.72MB]
Hanako MORIKAWA, Office of Medical Devices II, PMDA

Real-world considerations for constructing an academic registry for using regulatory decision-making
Masahiko FUJIHARA, Kishiwada Tokushukai Hospital

Lessons learned from using registry data for approval applications[775KB]
Yasuhiko MORITA, Nipro

Panel Discussion

10時5分から10時55分 Introduction of US - Japan regulatory system for software as a medical device

Points to consider in the review of the SaMD and action plan of accelerating the review process
~a. Japanese regulatory view[1.03MB]: Takatomo EZURA, Office of Software as a Medical Device, PMDA
b. US regulatory view: Aneesh Deoras, CDRH, FDA

The challenge for the development of SaMD in Japan ~ Industry perspective~[2.56MB]
Yuki SHIMAHARA, LPIXEL

Panel Discussion

10時55分から11時 Closing remarks and next steps