skip to content

Medical Device Vigilance (NIDS)

2018 AHC Medical Device Vigilance CoE Pilot training Speaker List

Diana Lee

  • Hyeonho KimDeputy Director,
    Medical Device Safety Bureau,
    Ministry of Food and Drug Safety (MFDS)
    • Day 1> Introduction
      • Overview of APEC Medical Device Vigilance Activities

Diana Lee

  • Eric WooRegional Director,
    Asia Pacific,
    ECRI Institute
    • Day 1> Session I
      • Roles and responsibilities of each stakeholder in the field of Medical Device Vigilance
    • Day 1> Session III (Facilitator)
      • Case Studies & Breakout Discussion
    • Day 2> Session IV
      • Horizon Scanning – how it could be effective to Medical Device Surveillance

Diana Lee

  • Patrick Revelle Director
    MedDRA MSSO
    • Day 1> Session I
      • Understanding MedDRA

Diana Lee

  • Ishikawa Hiroshi Technical Expert,
    Division of Standards for Medical Devices,
    Pharmaceuticals and Medical Devices Agency (PMDA)
    • Day 1> Session II
      • Integration of MDV system – How to exchange information between National Competent Authorities
      • IMDRF AE Terminology

Diana Lee

  • You Kyoung Lee Medical Doctor / professor
    Laboratory Medicine & Genetics
    Soonchunhyang University Bucheon Hospital
    • Day 1> Session III (Leader)
      • Case Studies & Breakout Discussion

Diana Lee

  • Ju Han KimProfessor
    Division of Biomedical Informatics,
    Seoul National University College of Medicine
    • Day 2> Session IV
      • Database construction in MDV for detecting national trend; is it really need and possible?

Diana Lee

  • Bum Sun Kwon
    Vice President/ Professor
    Dongguk University Hospital
    • Day 2> Session V
      • Operational experiences and challenges; how to move forward – Korea Perspective

Diana Lee

  • Terry Song Head of QA/RA
    Boston Scientific
    • Day 2> Session V
      • Operational experiences and challenges; how to move forward – Industry Perspective