ここから本文です。

Japan-US HBD East 2021 Think Tank Meeting

 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) 医薬品医療機器総合機構
(一社) 日本医療機器産業連合会

会議日程

2022年1月14日(金)8:00~11:00、1月21日(金)8:00~11:00

会場

Web開催(Zoom)

結果

Outcome Statement (後日掲載いたします。)

プログラム

詳細はこちら(Day1, Day2)をご覧ください。※日英同時通訳あり
Day1

8:00-8:20

Welcome Speeches

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8:20-8:40

Keynote Speeches

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

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8:40-8:50

Update of HBD Activity

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HBD Steering Committee
Erika NORO, Office of Medical Devices II, PMDA

PDF

HBD for Children
Kalkidan Molla, CDRH, FDA

PDF

8:50-9:25

Rethinking of the New Style of Global Clinical Trial <Section1: Clinical Design>

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

PDF

The outlook for Patient Involvement in Medical Device Development  ~US Regulatory View~
Michelle Tarver, CDRH, FDA

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Panel Discussion

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9:25-10:00

Rethinking of the New Style of Global Clinical Trial <Section2: GCP Inspection>

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Considerations for GCP inspections of global clinical trials
Kazuo KAWAHARA, Boston Scientific

PDF

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

PDF

Panel Discussion

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10:00-11:00

“How to promote the development of pediatric medical devices.”
~HBD for children~

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

PDF

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

PDF

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

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Panel Discussion

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Closing Remarks

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Day2

8:00-8:05

Opening remarks

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8:05-9:05

Initiatives to improve patient access to new medical devices

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Introduction and Perspective of new regulatory pathways
~ Japanese regulatory view~
Kanako SASAKI, MHLW

PDF

Introduction and Perspective of new regulatory pathways
~ US regulatory view~
Hiren Mistry, CDRH, FDA

PDF

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

a: PDF
b: -

Panel Discussion

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9:05-10:05

“Sustainable Development Goals in Real-world data collection”

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

PDF

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

PDF

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

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Lessons learned from using registry data for approval applications
Yasuhiko MORITA, Nipro

PDF

Panel Discussion

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10:05-10:55

Introduction of US - Japan regulatory system for software as a medical device

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

a: PDF
b: -

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

PDF

Panel Discussion

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10:55-11:00

Closing remarks and next steps

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