Program

7th November 2023 (Day 1)

Venue – Grand Hyatt Hotel Incheon, Republic of Korea

Time Topic Speakers
09:00 – 09:30 Offline Registration Participants
09:30 – 09:50 Intro and Welcome Message SCH APEC CoE
09:50 – 10:00 Photo session Participants
10:00 – 10:15 Coffee Break
10:15 – 10:45 Hands-on 1 - IMDRF Terminologies for medical device adverse event
• How to practice virtual hands-on cases on the SCH website		 Kichang Nam, Dongguk Univ.
11:00 – 12:00 Group activity for Hands-on 1 using virtual cases SCH APEC CoE team and participants
12:00 – 13:00 Lunch
13:00 – 14:00 Continue Group activity for Hands-on 1 using virtual cases SCH APEC CoE team and participants
14:00 – 14:30 PowerPoint preparation for Group Presentation
14:30 – 16:00 Group Presentation by Participants Kichang Nam, Dongguk Univ.
Soo Jeong Choi, SCH Univ
8th November 2023 (Day 2)

Venue – Grand Hyatt Hotel Incheon, Republic of Korea

Time Topic Speakers
09:00 – 09:15 Offline Registration Participants
09:15 – 09:45 Hands-on 2 – Classification of IVD medical devices
• How to practice virtual hands-on cases on the SCH website
• Explanation of Group work and Group Allocation		 Soe Ye Yint Tun, SCH Univ.
09:45 – 10:00 Coffee Break
10:00 – 11:00 Group activity for Hands-on 2 using virtual cases Participants
11:00 – 11:30 PowerPoint preparation for Group
11:30 – 12:30 Group Presentation for Hands-on 2 Hwansub Lim, Seoul Clinical Lab.
Soe Ye Yint Tun, SCH Univ.
12:30 – 12:45 Closing Day 2 and Lunch SCH APEC CoE
*The special session (In-person Hands-on Workshop) will only focus on the group work of hands-on 1 & 2. So, all participants need to watch the lecture videos online at the SCH website https://ebdiagnostics.org/schmc/index.do to complete the training.


Method Time Topic Speaker

  • Subject 1. Medical Devices

    • Objectives:
    • 1) To understand the requirement of clinical evaluation for medical devices based on IMDRF guidance
    • 2) To share the best practices in clinical investigation for medical devices
    • Core Curriculums:
    • 1) Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices (IMDRF/GRRP WG/N047: 2018)
    • 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 Event (IMDRF AE WG/N43 FINAL:2022)
    VOD Lectures 40 mins Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices Frances Richmond, Univ. of
    Southern California
    40 mins Understanding the Clinical Evidence and Clinical Evaluation, an overview of IMDRF MDCE WG/N55 & N56 document Yazid S. Alazwari, Saudi Food & Drug Authority
    40 mins Best practice for clinical evaluation, systematic approach to synthesize clinical experiences Eric Woo, ECRI
    40 mins IMDRF principles and best practices for Clinical Investigation of medical devices Jaesoon Choi, Ulsan Univ.
    40 mins Best practice for clinical evaluation, practical scientific approach for data generated through a literature review of IMDRF N56 You Kyoung Lee, SCH Univ.
    40 mins IMDRF terminologies for medical device adverse event Ishikawa Hiroshi,
    Univ. of Yamanashi
    Online Activity IMDRF terminologies for medical device adverse event

  • Subject 2. IVD Medical Devices

    • Objectives:
    • 1) To understand harmonized approach to the classification of IVD medical devices
    • Core curriculums:
    • 1) Principles of IVD Medical Devices Classification
      (IMDRF/IVD WG/ N64 Final: 2021 formerly GHTF/SG1/N045:2008)
    VOD Lectures 40 mins Classification of IVD medical devices Jina Kim, Ministry of Food and Drug Safety
    Online Activity Classification of IVD medical devices
    *This year’s offline training mainly focuses on Group works for IMDRF terminologies for medical device adverse events and Classification of IVD Medical Devices. The lectures are available only online at the SCH website and all offline and online participants need to watch the lecture videos.