AHC SCH Forum
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
- provide training on international standards and guidance to narrow the regulatory gaps within the APEC region and ultimately, facilitate regulatory convergence
- contribute to the training of international experts to strengthen their capabilities
- provide an opportunity to publicize the excellence in the system and industrial technology of Korea
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 |
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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 stakeholdersExplore the regulatory needs and discuss challenges, barriers, improvements opportunities for clinical investigations on innovative medical devices 09:05 - 09:15
(10min)[Presentation 1]
Regulatory approach to promote novel medical devices development in TaiwanDr. Te-Hsuen Chen (TFDA) 09:15 - 09:35
(20min)[Presentation 2]
Medical Devices Innovation
- Development of Digital Therapeutics
Dr. MinYoung Kim
(Cha University Hospital)09:35 - 09:55
(20min)[Presentation 3]
Clinical investigation in Digital Health
- Manufacturer’s perspectivesMr. Varun Veigas
(APACMed & Roche)09:55-10:55
(60min)[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 |
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-
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 PandemicDr. Kyoung Ho Roh(NHIS) 09:20 - 09:40 (20min) [Presentation 2]
Emergency Use Authorization (EUA) of IVDs during COVID-19 PandemicDr. Ho-Sang Jeong (MFDS) 09:40 - 10:00 (20min) [Presentation 3]
Issues and challenges for preparing COVID-19 related EUA of medical devices
- Industry perspectivesDr. Adelheid Schneider
(AHWP & Roche)10:00 - 10:20 (20min) [Presentation 4]
Global harmonization needs for future Pandemic Preparedness IVD experiences during COVID-19Dr. 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