APEC CoE Training(2021)

2021 SCH Medical Device CoE Training
September 1 – 17, 2021 | Online training (Available for 2.5 weeks, total 9.7 hours)
(Version updated on August 20th, 2021)

Method Time Topic Speaker
  • Subject 1. Clinical Evaluation (1.7-hr course)

    1) To understand the requirement of clinical evaluation for medical devices 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)
    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
    aesoon Choi
    (Asan Medical Center)
  • Subject 2. Risk Management (1.3-hr course)

    1) 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)
    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)

    1) 1) To build the ability to analyze medical device adverse events occurring in the healthcare system practice and express them using IMDRF terms & codes
    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)
    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)
    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)

    90 mins Live Video Conference 1 (September 10th, 2021))
    - Introduction of SCH CoE
    - Q&A and Panel discussion on Clinical evaluation
    Moderator: Frances Richmond (USC)
    120 mins Live Video Conference 2 (September 17th, 2021))
    - 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)