Japan-US HBD East 2021 Think Tank Meeting

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

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

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HBD for Children
Kalkidan Molla, CDRH, FDA

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

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

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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

Panel Discussion

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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.

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

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

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

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

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

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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

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Panel Discussion

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

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Panel Discussion

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