2023 A. The Latest Trends in Domestic and Foreign Laws and Regulations in the Medical Device Industry

  • Application Period 10 May - 7 Jun. 11:59pm
  • Attendance Period 14 Jun. 11:59pm
  • Price 33,000 Yen(tax included )

With the release of the "Guidelines on the Applicability of Programs to Medical Devices," we would like to provide an opportunity to look back on the "medical device programs" that are now regulated under the Pharmaceuticals and Medical Devices Law and to learn why these regulations were created so that we can better understand the guidelines that were released this time. We would like to provide you with information that will be useful for your practice. In addition, we will introduce the efforts of a company that has developed a smartphone application that utilizes the features of non-medical device software that already exists, and is aiming to enter the medical device business and obtain approval as a therapeutic application company. The presentation will also include an overview of the future of healthcare in Japan as the guidelines are announced, including the current state of healthcare finance.

※If you wish to attend onsite and watch on-demand, you will need to apply separately for on-demand delivery (additional fee will be charged).

※【Credit Card】You can watch the lecture until 6/14 (Wed.) after you receive the URL of the delivery.

※The URL will be sent with the lecture materials to the e-mail address you have registered for. Repeated viewing is available. Q&A session is not available. Early bird discount does not apply.

  • EN:開会の挨拶

    Time 5min

    EN:公⽴⼤学法⼈ 神奈川県⽴保健福祉⼤学教授公⽴⼤学法⼈
    神奈川県⽴保健福祉⼤学教授公⽴⼤学法⼈ 神奈川県⽴保健福祉⼤学教授

    EN:座長 昌子 久仁子

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    EN:元テルモ取締役上級執行役員一般財団法人機械振興協会 経済研究所 上級研究員公益財団法人医療機器センター 医療機器産業研究所 上級研究員

  • EN:北米における医療機器規制の動向

    Time 60min

    Q&A 10min

    EN:Siemens Healthineers,Head of Regulatory Policy – North America

    EN:野澤 進*online

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    2019-Present: Siemens Healthineers (Malvern, PA)
    • Head of Regulatory Policy – North America
    2001-2018: Becton, Dickinson and Company (Franklin Lakes, NJ)
    • Director, Technical and Regulatory Policy / Corp. Regulatory Affairs and Operations (2010–2018)
    • Director, Corporate Regulatory Affairs/Japan Region (2009)
    • Corporate Regulatory Affairs Liaison, Japan (2001–2008)
    2000-2001:Electro-Diagnostic Imaging, Inc. (San Mateo, CA)
    • Chief Operating Officer
    Leadership positions held:
    • Board of Directors, President and Chair (RAPS)
    • Vice Chair, Standards Committee (Medical Imaging & Technology Alliance, MITA)
    • Industry Chair and Special Representative, Japan Regulatory Working Group (AdvaMed)
    • Leadership Team member, RAQA Group (AMDD)
    Special Recognition:
    • Fellow, Regulatory Affairs Professional Society
    • Regulatory Affairs Certification (RAC) for the US and Europe

    Seminar Outline

    EN:医療機器は低リスクのものから高リスクのもの、ソフトウエアーや高度のアルゴリズムを駆使したもの、大きさも非常に小さいものからMRI等のような非常に大きなものまで多岐に渡り、それらの医療機器を規制するための法規制も非常に速いスピードで変化している。特にソフトウエアーの分野ではAI/MLを駆使した製品に関する規制についての議論が活発になされている。本セミナーでは、このように急激な変化を遂げている北米における医療機器規制についての方向性の概要を紹介し、MDUFA V下で実施されるパイロットについても可能な限り紹介する。

  • EN:日本における医療機器の規制の動向

    Time 60min

    Q&A 10min

    Exchange of business cards 10min

    EN:ジョンソン・エンド・ジョンソン株式会社 薬事本部

    EN:田中 志穂

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    EN:2019年4月~現在: 医機連法制委員会 委員長、医療機器規制と審査の最適化協働計画 運営会議
    2021年7月~現在: 医機連 プログラム医療機器規制対応SWG 主査 など

    所属
    2018年4月まで: 日本メドトロニック株式会社
    2018年5月~現在: ジョンソン・エンド・ジョンソン株式会社 薬事本部

    Seminar Outline

    EN:ここ数年、規制改革推進会議の中で、医療機器関係の規制についても様々な改革が行われつつあります。
    この規制改革推進会議で取り上げられたプログラム医療機器関係、また一般向け医療機器の広告などの課題を中心に、現在の検討状況についお話いたします。そのほか、必要性が益々高くなってきているサイバーセキュリティに関する対応に関しても、その概要に関して紹介します。

    規制改革推進会議にて取り上げられている課題
    プログラム医療機器における規制改革の検討状況
    医療機器におけるサイバーセキュリティ規制の動向
    そのほかの医療機器規制の動向

  • The Latest Developments in the Regulation of Medical Devices and In Vitro Diagnostic Medical Devices in the European Union (EU) and the United Kingdom (UK) – Insights from the Frontlines of EU MDR/IVDR and UKCA Marking System Evaluation and Certification."

    Time 60min

    Q&A 10min

    Exchange of business cards 10min

    Commercial Operations Director at BSI Group Japan (British Standards Institution) Regulatory Services, Japan (Medical Devices).

    EN:尾苗 潤哉

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    EN:2020年9月より、BSI(英国規格協会)にてEU MDR/IVDR,UKCA,MDSAP,ISO 13485, 薬機法認証の“予測可能な”デリバリーの卓越性を追求。医療機器の審査・認証を専門に扱う事業ストリームRegulatory Servicesでは、Commercial Operations Directorとして従事。
    BSI移籍まで約18年間所属したドイツ系の認証機関において、アジア太平洋地域、日本の医療機器の試験・審査・認証事業の責任者等を歴任

    Seminar Outline

    EN:激動の制度改革期を迎えている欧州連合(EU)と英国の医療機器・体外診断用医療機器の規制スキーム。医療機器を欧州連合(EU)と英国の新しい厳格な規制スキーム下でもシームレスに上市させることは、法的製造業者や適合性評価を行う認証機関にとって最優先の課題です。BSIは最大規模のEUノーティファイドボデイであり、EU離脱後の英国の新しいUKCAマーキング制度で認められた数少ないUKアプルーブドボデイとして、最大規模の審査・認証実績を重ねています。審査・認証プロジェクトの最前線での経験や気づきを交えた欧州連合(EU)・英国規制の最新動向を早期認証完了に向けた戦略的な取り組みや勘どころを添えて、わかりやすくお話致します。



    欧州連合(EU)・英国の医療機器・体外診断用医療機器の規制の最新動向
    審査・認証プロジェクトの最前線で得られた経験と気づき
    早期認証完了に向けた戦略的な取り組みや勘どころ

  • Time 60min

    Q&A 10min

    Exchange of business cards 10min

  • EN:閉会の挨拶

    Time 5min

    EN:公⽴⼤学法⼈ 神奈川県⽴保健福祉⼤学教授公⽴⼤学法⼈
    神奈川県⽴保健福祉⼤学教授公⽴⼤学法⼈ 神奈川県⽴保健福祉⼤学教授

    EN:座長 昌子 久仁子

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    EN:元テルモ取締役上級執行役員一般財団法人機械振興協会 経済研究所 上級研究員公益財団法人医療機器センター 医療機器産業研究所 上級研究員

2023 B. Medical DX

  • Application Period 10 May - 7 Jun. 11:59pm
  • Attendance Period 14 Jul. 11:59pm
  • Price 33,000 Yen(tax included )

With the release of the "Guidelines on the Applicability of Programs to Medical Devices," we would like to provide an opportunity to look back on the "medical device programs" that are now regulated under the Pharmaceuticals and Medical Devices Law and to learn why these regulations were created so that we can better understand the guidelines that were released this time. We would like to provide you with information that will be useful for your practice. In addition, we will introduce the efforts of a company that has developed a smartphone application that utilizes the features of non-medical device software that already exists, and is aiming to enter the medical device business and obtain approval as a therapeutic application company. The presentation will also include an overview of the future of healthcare in Japan as the guidelines are announced, including the current state of healthcare finance.

※If you wish to attend onsite and watch on-demand, you will need to apply separately for on-demand delivery (additional fee will be charged).

※【Credit Card】You can watch the lecture until 7/14 (Wed.) after you receive the URL of the delivery.

※The URL will be sent with the lecture materials to the e-mail address you have registered for. Repeated viewing is available. Q&A session is not available. Early bird discount does not apply.

  • EN:開会の挨拶

    Time 5min

    EN:公益財団法人医療機器センター

    EN:座長 鈴木 孝司

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    EN:2002年東京大学工学部卒、2007年同大学院修了。博士(科学)。東京女子医科大学 先端生命医科学研究所 助教
    2014年9月~2021年3月 公益財団法人医療機器センター 医療機器産業研究所にて、医療機器に関する調査研究や医工連携・産学連携・事業化支援に従事。4月からは認証事業部に異動し、製品審査・QMS審査に従事。

  • Time 60min

    Exchange of business cards 10min

  • Time 60min

    Exchange of business cards 10min

  • Time 60min

    Exchange of business cards 10min

  • Time 60min

    Exchange of business cards 10min

  • Time 40min

  • EN:閉会の挨拶

    Time 5min

    EN:座長 鈴木 孝司

2023 C. Business Opportunities in the Medical Device Industry

  • Application Period 10 May - 7 Jun. 11:59pm
  • Attendance Period 14 Jun. 11:59pm
  • Price 33,000 Yen(tax included )

With the release of the "Guidelines on the Applicability of Programs to Medical Devices," we would like to provide an opportunity to look back on the "medical device programs" that are now regulated under the Pharmaceuticals and Medical Devices Law and to learn why these regulations were created so that we can better understand the guidelines that were released this time. We would like to provide you with information that will be useful for your practice. In addition, we will introduce the efforts of a company that has developed a smartphone application that utilizes the features of non-medical device software that already exists, and is aiming to enter the medical device business and obtain approval as a therapeutic application company. The presentation will also include an overview of the future of healthcare in Japan as the guidelines are announced, including the current state of healthcare finance.

※If you wish to attend onsite and watch on-demand, you will need to apply separately for on-demand delivery (additional fee will be charged).

※【Credit Card】You can watch the lecture until 7/14 (Wed.) after you receive the URL of the delivery.

※The URL will be sent with the lecture materials to the e-mail address you have registered for. Repeated viewing is available. Q&A session is not available. Early bird discount does not apply.

  • EN:開会の挨拶

    Time 5min

    EN:公益財団法人医療機器センター 医療機器産業研究所
    事業化支援室
    上級研究員

    EN:座長 髙山 修一

  • Time 50min

    Q&A 10min

  • Time 50min

    Q&A 10min

    Exchange of business cards 10min

  • Time 50min

    Q&A 10min

    Exchange of business cards 10min

  • Time 50min

    Q&A 10min

    Exchange of business cards 10min

  • EN:産学連携による共同技術開発から医療機器の製品化まで

    Time 40min

    Q&A 10min

    Exchange of business cards 10min

    EN:道家 健仁

  • Time 5min

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