Agenda

2024 SCH APEC Medical Device CoE Training Lecture List
October 8th – 31st 2024 I Online Training



Method Time Topic Speaker

  • Subject 1: Medical Devices (5.2 hr course)

    • Objective:
    • 1) To understand the requirement of clinical evaluation for medical devices based on IMDRF guidance
    • 2) To share the best practices in the clinical investigation of medical devices
    • 3) To understand harmonized approach to the classification of medical devices based on GHTF guidance
    • Core Curriculums:
    • 1) Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices (IMDRF/GRRP WG/N047: FINAL: 2024 Edition 2)
    • 2) Clinical Investigation (IMDRF MDCE WG/N57FINAL:2019)
    • 3) Clinical Evaluation (IMDRF MDCE WG/N56FINAL:2019)
    • 4) Clinical Evidence (IMDRF MDCE WG/N55 FINAL:2019)
    • 5) IMDRF terminologies for categorized Adverse Events (IMDRF AE WG/N43 FINAL:2020)
    • 6) Principles of Medical Devices Classification (GHTF/SG1/ N77:2022)
    VOD Lectures 80 mins Part 1. Essential Principles of Safety and Performance: Medical Devices(50 mins)
    Part 2. Using Essential Principles of Safety and Performance in Medical Device Development(30 mins)     		Frances Richmond,
    University of Southern California
    40 mins Clinical Evidence and Clinical Investigation Saram Lee,
    Seoul National University
    40 mins Clinical Evaluation Nurneqman Nashreq bin Kosni,
    Ministry of Health Malaysia
    40 mins Medical Device Adverse Event Terminology Ishikawa Hiroshi,
    University of Yamanashi
    40 mins Classification of Medical Devices Naoki Morooka,
    JIRA
    40 mins Best Practice for Medical Devices Adverse Event Monitoring Kichang Nam,
    Dongguk University
    40 mins Adverse Event Investigation Process Eric Woo,
    ECRI
    Hands-on 1 IMDRF terminologies for medical device adverse event Soe Ye Yint Tun,
    SCH APEC CoE

  • Subject 2: IVD Medical Devices (1.2 hr course)

    • Objectives:
    • 1) To understand the essential principles of Safety and Performance of IVD medical devices
    • 2) To understand harmonized approach to the classification of IVD medical devices based on GHTF guidance
    • Core Curriculums:
    • 1) Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices (IMDRF/GRRP WG/N047: FINAL: 2024 Edition 2)
    • 2) Principles of IVD Medical Devices Classification (IMDRF/IVD WG/ N64 FINAL: 2021 formerly GHTF/SG1/N045:2008)
    VOD Lectures 40 mins Essential Principles of Safety and Performance: In Vitro Diagnostic Medical Devices You Kyoung Lee,
    SCH APEC CoE
    40 mins Classification of IVD medical devices Hwan Sub Lim,
    Seoul Clinical Laboratories
    Hands-on 2 Classification of IVD medical devices Soe Ye Yint Tun,
    SCH APEC Co

  • Untact Conferences (3 hr course)

    Untact
    Conferences    		 60 mins Live Video Conference 1 (October 8th, 2024, 09:00 AM KST)
    • Opening and Introduction of SCH CoE
    • How to participate in the 2024 SCH APEC MD CoE Training
    		 SCH APEC CoE
    120 mins Live Video Conference 2 (October 29th, 2024, 09:00 AM KST)
    • Best Practice for Clinical Investigation
    • Q & A session for each lecture
    • Closing the 2024 training     		Moderator
    - Frances Richmond,
    University of Southern California

    Speaker
    - Jaesoon Choi, Ulsan University

  • This year’s training is exclusively online. Participants can engage with the speakers during the Untact Conferences. For a more effective learning experience, we recommend attending both Untact Conferences.