2024 SCH APEC Medical Device CoE Training Lecture List
October 8th – 31st 2024 I Online Training
Method | Time | Topic | Speaker |
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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 California40 mins Clinical Evidence and Clinical Investigation Saram Lee,
Seoul National University40 mins Clinical Evaluation Nurneqman Nashreq bin Kosni,
Ministry of Health Malaysia40 mins Medical Device Adverse Event Terminology Ishikawa Hiroshi,
University of Yamanashi40 mins Classification of Medical Devices Naoki Morooka,
JIRA40 mins Best Practice for Medical Devices Adverse Event Monitoring Kichang Nam,
Dongguk University40 mins Adverse Event Investigation Process Eric Woo,
ECRIHands-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)
Objective:
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