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)
-
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 CoE40 mins Classification of IVD medical devices Hwan Sub Lim,
Seoul Clinical LaboratoriesHands-on 2 Classification of IVD medical devices Soe Ye Yint Tun,
SCH APEC Co -
Untact Conferences (3 hr course)
Untact
Conferences60 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 TrainingSCH 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 trainingModerator
- 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.