Program
Method | Topic |
---|---|
Subject 1. Clinical Evaluation |
|
VOD Lectures |
Clinical evidence and clinical evaluation |
Clinical investigation for medical devices: IMDRF’s principles | |
Clinical investigation: Best practices
- Practical experience, medical devices |
|
Subject 2. Risk Management |
|
VOD Lectures |
Application of risk management for medical devices (ISO 14971: 2019) |
Continuous quality improvement; medical devices adverse event and quality management system (GHTF SG3/N18: 2010) | |
Subject 3. Medical Device Vigilance |
|
VOD Lectures |
Generation of data related to the use of medical devices (Medical Devices Adverse Events, MDAE) |
Online Activity |
Case Study – IMDRF code application training for MDAE virtual cases |
Untact Conferences |
|
Untact Conference |
Live Video Conference 1 (September 10th) - Introduction of SCH CoE - Q&A and Panel discussion on Clinical evaluation |
Untact Conference |
Live Video Conference 2 (September 17th)
- Sharing results of virtual hands-on activity - Q&A and Panel discussion on IMDRF AE terminology & Risk Management - Final Remarks from Program Committee |
Method | Time | Topic | Speaker |
---|
-
Subject 1. Clinical Evaluation (1.7-hr course)
- Objectives:
- 1) To understand the requirement of clinical evaluation for IVD based on IMDRF guidance
- 2) To share the best practices on clinical investigation for medical devices
VOD
Lectures40 mins Clinical evidence and clinical evaluation Simon Singer (TGA) 40 mins Clinical investigation for medical devices: IMDRF’s principles Frances Richmond
(USC)20 mins Clinical investigation: Best practices
- Practical experience, medical devices
Jaesoon Choi
(Asan Medical Center) -
Subject 2. Risk Management (1.3-hr course)
- Objectives:
- To introduce ISO14971 and application of risk management in medical devices
VOD
Lectures40 mins Application of risk management for medical devices
(ISO 14971:2019)Jos van Vroonhoven
(Philips)40 mins Continuous quality improvement
medical devices adverse event and quality management system (GHTF SG3/N18: 2010)Eric Woo
(ECRI) -
Subject 3. Medical Device Vigilance (3.2-hr course)
- Objectives:
- 1) To build the ability to analyze medical device adverse events occurring in the healthcare system
- 2) To train IMDRF code application for medical device adverse events through virtual scenarios
VOD
Lectures40 mins Generation of data related to the use of medical devices (Medical Devices Adverse Events, MDAE)
(IMDRF/AE WG/N43 (Edition 4) FINAL:2020)Hiroshi Ishikawa
(PMDA)Online
activity150 mins Case study – IMDRF code application training for MDAE virtual cases(for Annex A-G) Survey - Selection of IMDRF codes (from Annex A-G) for virtual cases of MDAE Comment and Feedback -
Untact Conferences (3.5-hr course)
Untact Conference 90 mins Live Video Conference 1 (September 10th)
- Introduction of SCH CoE
- Q&A and Panel discussion on Clinical evaluation
Moderator: Frances Richmond
(USC)120 mins Live Video Conference 2 (September 17th)
- Sharing results of virtual hands-on activity
- Q&A and Panel discussion on IMDRF AE terminology & Risk Management
- Final Remarks from Program Committee
Moderator: Hwan Sub Lim
(SCL)