Introduction
Aim of SCH CoE Training
- Design training programs that meet PWA CoE Program Committee’s training objectives in the scope of Total Product Life Cycle of Medical Devices
- Deliver training programs effectively and promote harmonization and advancement of the use of standards in the assessment of medical devices among APEC region
- Assess the implementation and outcomes of CoE training and provide suggestions for future regulatory harmonization activities APEC LSIF RHSC
- Secure programs and a pool of lecturers and experts to disseminate the importance of the use of standards
About training
The 2021 SCH Medical Device CoE Training endeavor to train and educate ourselves of the topics across the total product life cycle of medical devices. The three main subject areas are Clinical Evaluation, Quality Management System and Medical Device Adverse Event. Through this training, we expect to expand our understanding of international standards, harmonize the regulatory systems for medical devices within APEC economies, build reliability on clinical tests conducted for medical devices, and thereby, share the benefits from the development of medical devices and healthcare with APEC economies.
Target Audience
- Regulators from APEC economies
- A wider range of stakeholders including academia, industry, etc
Venue
The training will be held virtually via video lectures and Untact Conference, due to COVID-19
Key Dates
Event | Date | |
Registration | August 9 – September 8, 2021 | |
Online training * All training materials are available during online training. |
September 1 – 21, 2021 |
|
Untact Conference *Trainees will be invited through Webex |
Day 1 | September 10, 2021 |
Day 2 | September 17, 2021 | |
Satisfaction Survey *After participating in 3 VOD lectures, 3 Online activity, and 1 Untact conference, you will be able to conduct a satisfaction survey |
September 10 – 21, 2021 | |
Certificate Requirements
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Certificates of participation will be issued to qualified trainees that have met the following minimum requirements:
- Completion of 3 or more VOD lectures
- Participation of 3 or more Online activity
- Attendance of at least 1 Untact Conference
- Completion of satisfaction survey
Hosting Institution

Co-Organizer
Program Committee
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Ministry of Food and Drug Safety
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APEC Harmonization Center
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MedDRA
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Korean Society for Laboratory Medicine
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Korean Society of Radiology
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ECRI
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Johnson and Johnson
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Japan Medical Imaging and Radiological Systems Industries
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Pharmaceuticals and Medical Devices Agency
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Dongguk University
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Roche
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University of Southern California
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Seoul Clinical Laboratories