2021 AHC-SCH Medical Device Forum
15th & 22nd (2-day online forum)

The ‘2021 AHC-SCH Medical Device Forum’ is an online forum co-hosted by the APEC Harmonization Center (AHC) and Soonchunhyang University (SCH), which will be held for 2 days from October 15th to 22th.

This forum aims to

This forum will focus on the clinical investigation of rapidly developing medical devices and COVID-19 related IVD medical devices, discussing the different policies of APEC economies, regulatory harmonization activities, and challenges.

AHC SCH Forum : Day 1 (October 15th, 2021)

15th & 22nd (2-day online forum)

Time Topic Speaker
  • Welcome and Introduction

    09:00 - 09:05 Opening Remarks Dr. You Kyoung Lee (SCH)
  • Part I: The Challenges in clinical investigation of rapidly developing medical devices
    - Different perspectives of stakeholders

    Explore the regulatory needs and discuss challenges, barriers, improvements opportunities for clinical investigations on innovative medical devices
    09:05 - 09:15
    [Presentation 1]
    Regulatory approach to promote novel medical devices development in Taiwan
    Dr. Te-Hsuen Chen (TFDA)
    09:15 - 09:35
    [Presentation 2]
    Medical Devices Innovation
    - Development of Digital Therapeutics
    Dr. MinYoung Kim
    (Cha University Hospital)
    09:35 - 09:55
    [Presentation 3]
    Clinical investigation in Digital Health
    - Manufacturer’s perspectives
    Mr. Varun Veigas
    (APACMed & Roche)
    [Panel Discussion]
    Clinical investigation for future innovation products
    - Barriers, challenges and improvement opportunities

      Moderator: Dr. Frances Richmond (USC)
    Dr. Jongmin Lee
    (Kyungpook University)
    Dr. Jaesoon Choi
    (Asan Medical Center)
    10:55 - 11:00 Closing Day 1

AHC SCH Forum : Day 2 (October 22th, 2021)

15th & 22nd (2-day online forum)

Time Topic Speaker
  • Part II: The Contribution and challenges to be solved of In Vitro Diagnostic Medical Devices in a Pandemic crisis

    Discuss current regulatory approaches and lessons learned from the clinical investigation of COVID-19 related IVD products, and reflect on the role of innovation and its future
    09:00 - 09:20 (20min) [Presentation 1]
    Clinical Investigation of IVDs during COVID-19 Pandemic
    Dr. Kyoung Ho Roh (NHIS)
    09:20 - 09:40 (20min) [Presentation 2]
    Emergency Use Authorization (EUA) of IVDs during COVID-19 Pandemic
    Dr. Ho-Sang Jeong (MFDS)
    09:40 - 10:00 (20min) [Presentation 3]
    Issues and challenges for preparing COVID-19 related EUA of medical devices
    - Industry perspectives
    Dr. Adelheid Schneider
    (AHWP & Roche)
    10:00 - 10:20 (20min) [Presentation 4]
    Global harmonization needs for future Pandemic Preparedness IVD experiences during COVID-19
    Dr. Razan Asally
    (AHWP & Saudi FDA)
    10:20 - 10:50 (30min) [Panel Discussion]
    Clinical Investigation for COVID-19 related IVD products
    - Problems and challenges, prioritize the regulatory needs

      Moderator: Dr. Frances Richmond (USC)
    Dr. You Kyoung Lee (SCH)
    Ms. Hye-jeong Sohn
    (Medi Step)
    Dr. Hwan Sub Lim (SCL)
    10:50 - 11:00 Closing Remarks