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
    • Core curriculums:
    • 1) Clinical Investigation (IMDRF MDCE WG/N57FINAL:2019)
    • 2) Clinical Evaluation (IMDRF MDCE WG/N56FINAL:2019)
    • 3) Clinical Evidence (IMDRF MDCE WG/N55 FINAL:2019)
    VOD
    Lectures    		 40 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
    • Core curriculums:
    • 1) ISO 14971:2019 Medical devices – Application of risk management to medical devices
    • 2) Quality management system – Medical Devices – Guidance on corrective action and preventive action and related QMS processes (GHTF SG3/N18: 2010)
    VOD
    Lectures    		 40 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
    • Core curriculums:
    • 1) IMDRF Terminologies for Categorized Adverse Event Reporting: terms, terminology, structure and codes
      (IMDRF/AE WG/N43 (Edition 4) FINAL:2020) & Updated Annexes A-G (Edition 5.0)
    VOD
    Lectures    		 40 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
    activity    		 150 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)