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Clinical and social impact of introducing Unique Device Identifier (UDI) to electronic health records and patient registries

Research Project

Project/Area Number 25350585
Research Category

Grant-in-Aid for Scientific Research (C)

Allocation TypeMulti-year Fund
Section一般
Research Field Medical engineering assessment
Research InstitutionJuntendo University

Principal Investigator

SASE Kazuhiro  順天堂大学, 医学部, 教授 (00420828)

Project Period (FY) 2013-04-01 – 2018-03-31
Project Status Completed (Fiscal Year 2017)
Budget Amount *help
¥5,200,000 (Direct Cost: ¥4,000,000、Indirect Cost: ¥1,200,000)
Fiscal Year 2017: ¥1,040,000 (Direct Cost: ¥800,000、Indirect Cost: ¥240,000)
Fiscal Year 2016: ¥1,040,000 (Direct Cost: ¥800,000、Indirect Cost: ¥240,000)
Fiscal Year 2015: ¥1,040,000 (Direct Cost: ¥800,000、Indirect Cost: ¥240,000)
Fiscal Year 2014: ¥1,040,000 (Direct Cost: ¥800,000、Indirect Cost: ¥240,000)
Fiscal Year 2013: ¥1,040,000 (Direct Cost: ¥800,000、Indirect Cost: ¥240,000)
Keywords医療技術評価学(HTA) / レギュラトリー・サイエンス / 医療機器 / レジストリ / 国際医療機器識別コード(UDI) / 国際規制調和 / リアル・ワールド・データ(RWD) / リアル・ワールド・エビデンス(RWE) / 医療技術評価(HTA) / UDI / リアル・ワールド・エビデンス / 補助人工心臓(LVAS) / 医療技術評価 (HTA) / 補助人工心臓 (LVAS) / レギュラトリーサイエンス / 人間医工学 / 国際情報交換(医療機器IMDRF) / 国際情報交換(日米実践と調和HBD) / 戦略的レジストリ連携(SCRN) / 医療情報・病院情報システム / 国際情報交換(医療機器国際IMDRF) / 国際情報交換(日米実践と調和 HBD) / 分散型レジストリ (ICCR/ICTVR) / 国際医療機器識別コード(UDI) / 国際情報交換(医療機器国際 IMDRF) / 国際情報交換(日米実践と調和;HBD) / 分散型レジストリ(ICCR/ICTVR)
Outline of Final Research Achievements

[Introduction] The balance between promotion of medical innovation and protection of patients is one of the most important issue of the Regulatory Science. Unique Device Identifier (UDI), a core element in the strategically coordinated registry network, is already mandated in the United States for phased implementation.
[Objective and Method] In this research, in collaboration with internationally coordinated registry networks, we examined the significance of UDI for health care providers.
[Result and Discussion] To build a sustainable ecosystem, the FDA highlighted the significance of UDI in care providers through its public-private partnership (MDEpiNet). Through Japan-US Harmonization by Doing (HBD), this study supported an internationally coordinated registry network (INTERMACS/J-MACS). Our experience was shared among Japanese stakeholders, and was referenced in the guidance document of the International Medical Devices Regulators Forum (IMDRF) as being applicable to other fields.

Report

(6 results)
  • 2017 Annual Research Report   Final Research Report ( PDF )
  • 2016 Research-status Report
  • 2015 Research-status Report
  • 2014 Research-status Report
  • 2013 Research-status Report
  • Research Products

    (71 results)

All 2018 2017 2016 2015 2014 2013 Other

All Int'l Joint Research (3 results) Journal Article (22 results) (of which Int'l Joint Research: 2 results,  Peer Reviewed: 9 results,  Open Access: 5 results,  Acknowledgement Compliant: 4 results) Presentation (40 results) (of which Int'l Joint Research: 11 results,  Invited: 21 results) Book (1 results) Remarks (3 results) Funded Workshop (2 results)

  • [Int'l Joint Research] FDA (Dr. Marinac-Dabic)/Cornell University (Dr. Art Sedrakyan)/Duke University (Dr. Mitchell Krucoff)(米国)

    • Related Report
      2017 Annual Research Report
  • [Int'l Joint Research] Cornell University/Harvard University/Duke University(米国)

    • Related Report
      2016 Research-status Report
  • [Int'l Joint Research] Cornell University/Harvard University/Duke University(米国)

    • Related Report
      2015 Research-status Report
  • [Journal Article] Tools for Assessing the Usability of Registries in Support of Regulatory Decision-Making.2018

    • Author(s)
      Marinac Dabic D. et al. on behalf of IMDRF/Registry WG
    • Journal Title

      International Medical Device Regulators Forum (IMDRF)

      Volume: N46 Pages: 1-30

    • Related Report
      2017 Annual Research Report
    • Peer Reviewed / Open Access / Int'l Joint Research
  • [Journal Article] がんと循環器診療の融合をめざす新たな学際領域 Cardio-Oncology2018

    • Author(s)
      佐瀬一洋、向井幹夫、藤原康弘
    • Journal Title

      週刊医学界新聞

      Volume: 3265 Pages: 1-1

    • Related Report
      2017 Annual Research Report
    • Open Access
  • [Journal Article] Japanese registry for Mechanically Assisted Circulatory Support: First report2017

    • Author(s)
      Nakatani Takeshi、Sase Kazuhiro、Oshiyama Hiroaki、Akiyama Masatoshi、Horie Masao、Nawata Kan、Nishinaka Tomohiro、Tanoue Yoshihisa、Toda Koichi、Tozawa Masao、Yamazaki Shunichi、Yanase Masanobu、Ohtsu Hiroshi、Ishida Michiko、Hiramatsu Ayaka、Ishii Kensuke、Kitamura Soichiro
    • Journal Title

      The Journal of Heart and Lung Transplantation

      Volume: 36 Issue: 10 Pages: 1087-1096

    • DOI

      10.1016/j.healun.2017.08.002

    • Related Report
      2017 Annual Research Report
    • Peer Reviewed / Open Access
  • [Journal Article] 日本における薬価制度と医療技術評価(HTA) -「国民皆保険制度の持続性」と「イノベーションの推進」の両立 -2017

    • Author(s)
      佐瀬一洋, 大津洋, 信濃裕美, 松岡淨, 米本直裕
    • Journal Title

      呼吸器内科

      Volume: 31 Pages: 367-375

    • Related Report
      2017 Annual Research Report
  • [Journal Article] Cardio-Oncologyの現状と課題2017

    • Author(s)
      佐瀬一洋, 南学, 赤澤宏, 室原温明, 向井幹夫
    • Journal Title

      心臓

      Volume: 49 Pages: 797-821

    • NAID

      130007433500

    • Related Report
      2017 Annual Research Report
  • [Journal Article] がん治療に関連する心疾患からがんサバイバーを守る -重要性を増すCardio-Oncology-2017

    • Author(s)
      佐瀬一洋
    • Journal Title

      新薬と臨牀

      Volume: 66 Pages: 813-820

    • Related Report
      2017 Annual Research Report
  • [Journal Article] リアル・ワールド・エビデンスと医療機器レジストリ -IMDRFレジストリ分科会における国際整合化の流れと戦略的レジストリ連携の方法論-2017

    • Author(s)
      佐瀬一洋, 大津洋, 米本直裕, 信濃裕美, 松岡淨
    • Journal Title

      医薬品医療機器レギュラトリーサイエンス

      Volume: 48 Pages: 533-541

    • Related Report
      2017 Annual Research Report
  • [Journal Article] 希少がんにおける臨床開発の問題と欧米との比較2017

    • Author(s)
      佐瀬一洋
    • Journal Title

      腫瘍内科

      Volume: 19 Pages: 610-617

    • Related Report
      2017 Annual Research Report
  • [Journal Article] Methodological Principles in the Use of International Medical Device Registry Data.2017

    • Author(s)
      Marinac Dabic D, et al. IMDRF/Registry WG
    • Journal Title

      International Medical Device Regulators Forum (IMDRF)

      Volume: -

    • Related Report
      2016 Research-status Report
    • Peer Reviewed / Open Access / Int'l Joint Research
  • [Journal Article] 医療機器におけるリアル・ワールド・エビデンスの活用 -戦略的レジストリ連携の現状と課題-2017

    • Author(s)
      佐瀬 一洋
    • Journal Title

      医療機器産業研究所 スナップショット

      Volume: 16

    • Related Report
      2016 Research-status Report
    • Open Access
  • [Journal Article] 戦略的レジストリ連携ネットワークによる次世代医療機器評価システムの構築 -米国FDAを中心とした産官学連携MDEpiNet-PPPからの最新報告とその日本への影響-2016

    • Author(s)
      佐瀬一洋、松岡淨、大津洋
    • Journal Title

      医薬品医療機器レギュラトリーサイエンス(PMDRS)

      Volume: 47 Pages: 45-49

    • Related Report
      2015 Research-status Report
    • Acknowledgement Compliant
  • [Journal Article] 人を対象とする医学研究における重篤な有害事象報告に関する研究 -国際基準から見た統合指針の特徴と多施設共同試験の運用-2015

    • Author(s)
      信濃裕美、大津洋、松岡淨、富野康日己、佐瀬一洋
    • Journal Title

      Jpn Pharmacol Ther (薬理と治療)

      Volume: 43 suppl2

    • Related Report
      2015 Research-status Report
    • Peer Reviewed / Acknowledgement Compliant
  • [Journal Article] Patient Registry: Essential Princiles (Proposed Document for Public Comment)2015

    • Author(s)
      IMDRF Registry Working Group: Marinac-Dabic D, Normand SL, Sedrakyan A, Tchang J, Armstrong R, Nelissen RGHH, Labek G, Bjork M, Sase K, Handa N, Usami S, Murakami M, Piscoi P, Fandja P, Thorelius J, Crosbie A, Graves S, Vicente M, Ribeiro M, Valeeva A, Shimabukuro K
    • Journal Title

      IMDRF (http://www.imdrf.org/consultations/cons-essential-principles-151124.asp, Accessed April 1, 2016)

      Volume: NA

    • Related Report
      2015 Research-status Report
    • Peer Reviewed
  • [Journal Article] 持続可能なエコシステムとしての分散型レジストリとUDI – 薬事法の改正から国際医療機器連携まで -.2015

    • Author(s)
      佐瀬一洋
    • Journal Title

      医薬品医療機器レギュラトリーサイエンス, PMDRS

      Volume: 46 Pages: 207-215

    • Related Report
      2014 Research-status Report
    • Acknowledgement Compliant
  • [Journal Article] Atheroma Progression in Obese Early-stage Diabetic Japanese Patients in Response to Glycemic Control: Sub-analysis from the DIANA Study2015

    • Author(s)
      Kataoka Y, Yasuda S, Miyamoto Y, Sase K, Kosuge M, Kimura K, Yoshimasa Y, Miyazaki S
    • Journal Title

      Journal of Atherosclerosis and Thrombosis

      Volume: 22 Issue: 7 Pages: 697-705

    • DOI

      10.5551/jat.26237

    • NAID

      130005089131

    • ISSN
      1340-3478, 1880-3873
    • Related Report
      2014 Research-status Report
    • Peer Reviewed
  • [Journal Article] レギュラトリーサイエンスと持続可能な医療機器レジストリ. – TAVRレジストリにおけるUDIの活用と日本の貢献 -.2014

    • Author(s)
      佐瀬一洋
    • Journal Title

      医薬品医療機器レギュラトリーサイエンス, PMDRS

      Volume: 45 Pages: 587-592

    • Related Report
      2014 Research-status Report
    • Acknowledgement Compliant
  • [Journal Article] Results of the prospective multicenter Japanese bridge to transplant study with a continuous-flow left ventricular assist device.2014

    • Author(s)
      Kyo S, Ono M, Sawa Y, Nakatani T, Tabayashi K, Saiki Y, Tominaga R; HeartMate II Japanese Clinical Investigators.
    • Journal Title

      J Artif Organs.

      Volume: 17 Issue: 2 Pages: 142-148

    • DOI

      10.1007/s10047-013-0752-y

    • Related Report
      2014 Research-status Report
    • Peer Reviewed
  • [Journal Article] Clinical Predictors of Atheroma Progression Despite Optimal Glycemic Control in Early-Stage Diabetic Patients with Coronary Artery Disease: Insight from the DIANA Study2014

    • Author(s)
      Kataoka Y, Yasuda S, Miyamoto Y, Sase K, Kosuge M, Kimura K, Yoshimasa Y, Miyazaki S
    • Journal Title

      Journal of atherosclerosis and thrombosis

      Volume: 21

    • NAID

      130004444735

    • Related Report
      2013 Research-status Report
    • Peer Reviewed
  • [Journal Article] ビッグ・データの時代における医療機器安全監視イノベーション: UDI を活用した国際心血管レジストリ連携 (ICCR)2013

    • Author(s)
      佐瀬一洋
    • Journal Title

      医薬品医療機器レギュラトリーサイエンス

      Volume: 44 Pages: 838-844

    • Related Report
      2013 Research-status Report
  • [Journal Article] Genome-wide response to antihypertensive medication using home blood pressure measurements: A pilot study nested within the HOMED-BP study2013

    • Author(s)
      Kamide K, Asayama K, Katsuya T, Ohkubo T, Hirose T, Inoue R, Metoki H, Kikuya M, Obara T, Hanada H, Thijs L, Kuznetsova T, Noguchi Y, Sugimoto K, Ohishi M, Morimoto S, Nakahashi T, Takiuchi S, Ishimitsu T, Tsuchihashi T, Soma M, Higaki J, Matsuura H, Shinagawa T, Sasaguri T, Miki T, Takeda K, Shimamoto K, Ueno M, Hosomi N, Kato J, Komai N, Kojima S, Sase K, Miyata T, Tomoike H, Kawano Y, Ogihara T, Rakugi H, Staessen JA, Imai Y
    • Journal Title

      Pharmacogenomics

      Volume: 14 Issue: 14 Pages: 1709

    • DOI

      10.2217/pgs.13.161

    • URL

      https://pure.teikyo.jp/en/publications/c85d1b26-a0cb-42d3-89b0-92922a561e9f

    • Related Report
      2013 Research-status Report
    • Peer Reviewed
  • [Journal Article] 抗血小板療法のレギュラトリー・サイエンス:―より有効に, より安全に, より効率的に―2013

    • Author(s)
      佐瀬一洋
    • Journal Title

      日本血栓止血学会誌

      Volume: 24 Pages: 269-281

    • NAID

      130003367351

    • Related Report
      2013 Research-status Report
  • [Journal Article] ポストゲノム時代をリードする新薬開発 Molecular profiling directed therapy わが国における希少がんに対する新薬研究開発と諸問題 医学への敬意・医療への感謝・研究への期待2013

    • Author(s)
      佐瀬一洋
    • Journal Title

      腫瘍内科

      Volume: 13 Pages: 123-128

    • Related Report
      2013 Research-status Report
  • [Presentation] Real World Evidence.2018

    • Author(s)
      Misti Malone (FDA), Kazuhiro Sase (Juntendo Univ), co-chair
    • Organizer
      Annual Symposium of Cardiovascular Research Technologies (CRT2018), Washington D.C., USA.
    • Related Report
      2017 Annual Research Report
    • Int'l Joint Research
  • [Presentation] チーム医療におけるCardio-Oncologyの役割2018

    • Author(s)
      信濃裕美、三浦佳代、米本直裕、大津洋、松岡淨、齊藤光江、佐瀬一洋
    • Organizer
      第82回日本循環器学会学術集会 チーム医療セッション
    • Related Report
      2017 Annual Research Report
  • [Presentation] 肉腫の新規治療を考える2018

    • Author(s)
      角美奈子、佐瀬一洋(共同座長)
    • Organizer
      第1回日本サルコーマ治療学会 特別企画2
    • Related Report
      2017 Annual Research Report
  • [Presentation] The New Paradigm: Real World Evidence for Device Evaluation - A Global Perspective.2017

    • Author(s)
      Daniel A Canos (FDA), Kazuhiro Sase (Juntendo Univ), co-chair
    • Organizer
      Transcatheter Cardiovascular Therapeutics Congress (TCT2017), Denver, CO, USA.
    • Related Report
      2017 Annual Research Report
    • Int'l Joint Research
  • [Presentation] Lessons Learned from Harmonizationby Doing (HBD) and international collaboration.2017

    • Author(s)
      Kazuhiro Sase
    • Organizer
      MDEpiNet Annual Meeting, White Oak Campus, Food and Drug Administration (FDA), USA
    • Related Report
      2017 Annual Research Report
    • Int'l Joint Research
  • [Presentation] Commentary, Education perspective & current surgical research training, IDEAL Stakeholder Engagement in Education.2017

    • Author(s)
      Kazuhiro Sase
    • Organizer
      IDEAL 2017 Annual Conference, New York Academy of Medicine, NY, USA
    • Related Report
      2017 Annual Research Report
  • [Presentation] Cardio-Oncologyへの期待 -患者の立場から-2017

    • Author(s)
      佐瀬一洋
    • Organizer
      日本臨床薬理学会学術集会
    • Related Report
      2017 Annual Research Report
  • [Presentation] Real World Evidence - VIew from Japanese Academia -2017

    • Author(s)
      Kazuhiro Sase
    • Organizer
      Japan-US HBD East 2017 Think Tank Meeting, NCGM, Tokyo, Japan
    • Related Report
      2017 Annual Research Report
    • Int'l Joint Research
  • [Presentation] 我が国におけるCardio-Oncology2017

    • Author(s)
      野原隆司、佐瀬一洋(共同座長)
    • Organizer
      第65回日本心臓病学会学術集会
    • Related Report
      2017 Annual Research Report
  • [Presentation] Cardio-Oncologyの視点からのチーム医療の検討について2017

    • Author(s)
      信濃裕美、佐瀬一洋、三浦佳代、齊藤光江、米本直裕、大津洋、松岡淨
    • Organizer
      第245回日本循環器学会関東甲信越地方会
    • Related Report
      2017 Annual Research Report
  • [Presentation] 希少がん対策と医薬品開発2017

    • Author(s)
      佐瀬一洋
    • Organizer
      PMDA科学委員会 第4回希少がん専門部会
    • Related Report
      2017 Annual Research Report
  • [Presentation] Using Real-World Evidence to Support Marketing, Post-marketing safety measures and Regulatory Decisions.2017

    • Author(s)
      Sase K
    • Organizer
      Japan FDA HBD sessions - CRT17
    • Place of Presentation
      Hampton Room, Omni Shoreham Hotel (Washington D.C., USA)
    • Related Report
      2016 Research-status Report
    • Int'l Joint Research / Invited
  • [Presentation] 医療機器のイノベーションとレギュラトリーサイエンス -エビデンス構築の方法論から医療技術評価(HTA)まで-2017

    • Author(s)
      佐瀬 一洋
    • Organizer
      早稲田大学医療レギュラトリー研究所 公開シンポジウム 補助人工心臓の研究開発から学ぶ
    • Place of Presentation
      早稲田大学先端生命医科学センター
    • Related Report
      2016 Research-status Report
    • Invited
  • [Presentation] 医療イノベーションの推進と持続可能なエコシステムの構築2017

    • Author(s)
      佐瀬 一洋
    • Organizer
      日本皮膚科学会 第79回沖縄地方会
    • Place of Presentation
      沖縄県医師会館講堂
    • Related Report
      2016 Research-status Report
    • Invited
  • [Presentation] 希少がんにおける臨床開発の問題2017

    • Author(s)
      佐瀬 一洋
    • Organizer
      抗悪性腫瘍薬開発フォーラム
    • Place of Presentation
      がん研究会有明病院 吉田富三記念講堂
    • Related Report
      2016 Research-status Report
    • Invited
  • [Presentation] 重要性を増すCardio-Oncology2016

    • Author(s)
      南 学, 佐瀬 一洋
    • Organizer
      第64回日本心臓病学会学術集会(シンポジウム6)
    • Place of Presentation
      東京国際フォーラム
    • Related Report
      2016 Research-status Report
  • [Presentation] 医療イノベーションへの期待と戦略的レジストリ連携の実践 -FDAのMDEpiNetからIMDRFガイダンス文書まで-2016

    • Author(s)
      佐瀬 一洋
    • Organizer
      第188回レギュラトリーサイエンス・エキスパート研修会専門コース
    • Place of Presentation
      日本薬学会長井記念ホール
    • Related Report
      2016 Research-status Report
    • Invited
  • [Presentation] モデル授業から得られたがん教育への感謝と期待2016

    • Author(s)
      佐瀬 一洋
    • Organizer
      KOBE教育フォーラム
    • Place of Presentation
      神戸市総合教育センター
    • Related Report
      2016 Research-status Report
    • Invited
  • [Presentation] 薬機法および統合指針とGCP -ICH-E6(R2)改訂のポイントとISO9000/ISO14155-2016

    • Author(s)
      佐瀬 一洋
    • Organizer
      Masters Forum 2016 医工連携機構
    • Place of Presentation
      秋葉原UDX Gallery
    • Related Report
      2016 Research-status Report
    • Invited
  • [Presentation] Cardio-Oncology as an Emerging Paradigm in Asia2016

    • Author(s)
      Sase K
    • Organizer
      International Society of Cardiomyopathies and Heart Failure (ISCHF2016)
    • Place of Presentation
      Kyoto International Conference Center
    • Related Report
      2016 Research-status Report
    • Int'l Joint Research / Invited
  • [Presentation] Harmonization by Data (co-chair, panel discussion)2016

    • Author(s)
      Krucoff MW and Sase K
    • Organizer
      HBD2016 Think Tank West - TCT2016
    • Place of Presentation
      The Walter E. Washington Convention Center (Washington D.C., USA)
    • Related Report
      2016 Research-status Report
    • Int'l Joint Research / Invited
  • [Presentation] Case Studies of Capacity Building in Asia: Education and Training Approaches - The Japanese Experience-2016

    • Author(s)
      Sase K
    • Organizer
      ApacMed Regulatory Affairs Summit. Medtech Forum Asia Pacific 2016.
    • Place of Presentation
      Suntec Singapore Convention Center. (Singapore)
    • Related Report
      2016 Research-status Report
    • Int'l Joint Research / Invited
  • [Presentation] Discussions through IMDRF Registry WG - Bridging Unmet Medical Device Ecosystem Needs with Strategically Coordinated Registries Networks -.2015

    • Author(s)
      Sase K
    • Organizer
      HBD Special Program. The 22nd Kamakura Live Demonstration.
    • Place of Presentation
      Hamagin Hall (Yokohama)
    • Year and Date
      2015-12-18
    • Related Report
      2015 Research-status Report
    • Int'l Joint Research
  • [Presentation] Bridging Innovation and Evaluation Internationally: MDEpiNet as a Citizen of the World.2015

    • Author(s)
      Normand S-L, Sase K
    • Organizer
      2015 MDEpiNet PPP Annual Meeting
    • Place of Presentation
      FDA Headquaters, White Oak Campus (USA)
    • Year and Date
      2015-10-02
    • Related Report
      2015 Research-status Report
    • Int'l Joint Research
  • [Presentation] Advancing Regulatory Science-based Registry. -HBD, MDEpiNet, and IMDRF-RWG to create sustainable ecosystems for medical device innovation-.2015

    • Author(s)
      Sase K
    • Organizer
      US-Japan HBD East 2015 Think Tank Meeting
    • Place of Presentation
      Shimadzu Hall (Kyoto)
    • Year and Date
      2015-09-18
    • Related Report
      2015 Research-status Report
    • Int'l Joint Research
  • [Presentation] 持続可能なエコシステムとしての分散型レジストリ連携とUDI. -FDAの産官学連携(MDEpiNet-PPP)からIMDRFのレジストリ分科会まで-2015

    • Author(s)
      佐瀬一洋
    • Organizer
      第5回レギュラトリーサイエンス学会
    • Place of Presentation
      一橋講堂(東京)
    • Year and Date
      2015-09-15
    • Related Report
      2015 Research-status Report
  • [Presentation] 医療イノベーションへの期待と医療機器臨床評価の国際化. -日米共同試験の実践(HBD)から国際レジストリ連携(IMDRF/RWG)まで-2015

    • Author(s)
      佐瀬一洋
    • Organizer
      第5回レギュラトリーサイエンス学会
    • Place of Presentation
      一橋講堂(東京)
    • Year and Date
      2015-09-15
    • Related Report
      2015 Research-status Report
  • [Presentation] 国際化時代のレギュラトリーサイエンスと臨床評価 -リスク管理計画(RMP)から国際レジストリ連携まで-2015

    • Author(s)
      佐瀬一洋
    • Organizer
      第13回扇研究会
    • Place of Presentation
      きたのホール(大阪)
    • Year and Date
      2015-06-27
    • Related Report
      2015 Research-status Report
    • Invited
  • [Presentation] 国際化時代の臨床研究と統合指針の重要性 -臨床現場における利益相反への対応から国際整合化の実践まで-2015

    • Author(s)
      佐瀬一洋
    • Organizer
      第4回臨床研究に関する講演会 ビッグ・データの時代とレギュラトリーサイエンス
    • Place of Presentation
      日本医科大学 橘桜ホール(東京)
    • Year and Date
      2015-06-22
    • Related Report
      2015 Research-status Report
    • Invited
  • [Presentation] Session 1, Harmonization by Data – What Can be Learned from Combining Japan-USA Post-Market Cardiovascular Registires?.2015

    • Author(s)
      Sase K. and Marinac-Dabic D.
    • Organizer
      US-Japan FDA Town Hall. Cardiovascular Research Technologies (CRT2015).
    • Place of Presentation
      Omni Shoreham, Washington, D.C.
    • Year and Date
      2015-02-23
    • Related Report
      2014 Research-status Report
    • Invited
  • [Presentation] Working Group 2 Report. INTERMACS-JMACS, Models for International and Inter-Agency Registries-. Harmonization by Doing (HBD) West Think Tank Open Meeting.2014

    • Author(s)
      Sase K.
    • Organizer
      International Medical Device Regulators Forum (IMDRF), Open Session1, HBD: Past, Present, and Future.
    • Place of Presentation
      Embassy Row, Washington, D.C.
    • Year and Date
      2014-09-19
    • Related Report
      2014 Research-status Report
  • [Presentation] Predictable and SuStainable Implementation of National and International Registries. –The Impact of Unique Device Identification (UDI) on Healthcare Providers -.2014

    • Author(s)
      Sase K.
    • Organizer
      PMDA/FDA Town-Hall Meeting. The 23rd Annual Meeting of the Japanese Association of Cardiovascular Intervention and Therapeutics (CVIT2014).
    • Place of Presentation
      Nagoya, Japan
    • Year and Date
      2014-07-26
    • Related Report
      2014 Research-status Report
  • [Presentation] PMS in the Japan-US HBD: Lessons Learned from INTERMACS/J-MACS2014

    • Author(s)
      Kazuhiro Sase
    • Organizer
      Japan-US Synergies in Global Medical Device Evaluation & Innovation. Cardiovascular Research Technologies (CRT2014)
    • Place of Presentation
      Hampton Room, Omni Shoreham (Washington D.C., U.S.A.)
    • Related Report
      2013 Research-status Report
    • Invited
  • [Presentation] "Harmonization by Data", Goals for Global TAVR Registry Data - Japan Academia View -2014

    • Author(s)
      Kazuhiro Sase, Hisao Ogawa
    • Organizer
      Japan-US Synergies in Global Medical Device Evaluation & Innovation. Cardiovascular Research Technologies (CRT2014)
    • Place of Presentation
      Hampton Room, Omni Shoreham (Washington D.C., U.S.A.)
    • Related Report
      2013 Research-status Report
    • Invited
  • [Presentation] INTERMACS-JMACS: A Model of International and Inter-Agency Registries2014

    • Author(s)
      Kazuhiro Sase
    • Organizer
      MDEpiNet Think Tank Program (Food and Drug Administration)
    • Place of Presentation
      Parc55 Wyndham Hotel (San Francisco, U.S.A.)
    • Related Report
      2013 Research-status Report
    • Invited
  • [Presentation] Global Harmonization for Medical Device Innovation - Future Direction2013

    • Author(s)
      Kazuhiro Sase
    • Organizer
      The 22nd Annual Meeting of the Japanese Associationof Cardiovascular Intervention and Therapeutic (CVIT2013)
    • Place of Presentation
      Room D (Kairaku 2, Kobe Portopia Hotel)
    • Related Report
      2013 Research-status Report
    • Invited
  • [Presentation] Participation of Academia in Post-Market Management2013

    • Author(s)
      Kazuhiro Sase
    • Organizer
      US-Japan HBD East 2013 Think Tank Meeting
    • Place of Presentation
      Yayoi Memorial Hall, Tokyo Women's Medical College
    • Related Report
      2013 Research-status Report
    • Invited
  • [Presentation] 先端医療へのアクセス2013

    • Author(s)
      佐瀬一洋
    • Organizer
      日本薬学会 第10回 医薬品評価フォーラム
    • Place of Presentation
      長井記念館(東京)
    • Related Report
      2013 Research-status Report
    • Invited
  • [Presentation] わが国における希少がんでの医薬品開発試験規制上の諸問題2013

    • Author(s)
      佐瀬一洋
    • Organizer
      第15回 抗悪性腫瘍薬開発フォーラム
    • Place of Presentation
      がん研究会有明病院 吉田富三記念講堂(東京)
    • Related Report
      2013 Research-status Report
    • Invited
  • [Presentation] Post-Marketing Surveillance: Comment from the co-chair2013

    • Author(s)
      Kazuhiro Sase
    • Organizer
      Japan-US Synergy Reserach Opportunities in Global Medical Device Innovation. Transcatheter Cardiovascular Therapeutics (TCT2013)
    • Place of Presentation
      Room 238, Moscone Center South. (San Francisco, U.S.A.)
    • Related Report
      2013 Research-status Report
    • Invited
  • [Book] がん患者の心臓を守る!腫瘍循環器学Q&A2018

    • Author(s)
      伊藤浩、向井幹夫(編)、佐瀬一洋ほか(著)
    • Total Pages
      151
    • Publisher
      文光堂
    • ISBN
      9784830619434
    • Related Report
      2017 Annual Research Report
  • [Remarks] 研究者情報データベース

    • URL

      https://www.juntendo.ac.jp/graduate/kenkyudb/search/researcher.php?MID=3652

    • Related Report
      2017 Annual Research Report
  • [Remarks] IMDRF Registry WG Essential Principles

    • URL

      http://www.imdrf.org/consultations/cons-essential-principles-151124.asp

    • Related Report
      2015 Research-status Report
  • [Remarks] MDEpiNet-PPP International Committee (co-chair)

    • URL

      http://mdepinet.org/who-we-are/kazuhiro-sase-md-phd/

    • Related Report
      2015 Research-status Report
  • [Funded Workshop] Japan-US HBD East 2017 Think Tank Meeting2017

    • Related Report
      2017 Annual Research Report
  • [Funded Workshop] IMDRF Registry Working Group2015

    • Place of Presentation
      Pharmaceuticals and Medical Devices Agency (PMDA, Tokyo), National Center for General Medicine (NCGM, Tokyo)
    • Year and Date
      2015-04-20
    • Related Report
      2015 Research-status Report

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Published: 2014-07-25   Modified: 2022-06-07  

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