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 2024 SCH APEC Medical Device CoE Training endeavors to train and educate ourselves on the topics across the total product life cycle of medical devices. The two main subject areas are Medical Devices and IVD medical devices. Through this training, we expect to expand the 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 within APEC economies.
Target Audience
- Regulators from APEC economies
- A wider range of stakeholders including academia, industry, etc
Venue
The training will be held virtually at SCH website with pre-recorded lecture videos, hands-on exercises and untact conference
Key Dates
Event | Date | |
Registration | August 3rd week – 16th October 2024 | |
Training * All training materials are available during online training. |
Online Training : 8th - 31st October 2024 Untact Conference : 8th October , 29th October 2024 |
|
Satisfaction Survey (After studying 6 or more lecture videos, practicing 4 online activities of Hands-on 1, 6 online activities of Hands-on 2, and attending one or both Untact Conferences, you will be able to conduct the satisfaction survey) |
November, 2024 |
Certificate Requirements
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Certificates of participation will be issued to qualified trainees that have met the following minimum requirements:
- Complete watching 6 or more VOD lectures
- Practice at least 4 online activities of Hands-on 1 (IMDRF adverse event terminology)
- Practice at least 6 online activities of Hands-on 2 (Classification of IVD Medical Devices)
- Attend one or both Untact Conferences
- Completion of the Satisfaction Survey
Hosting Institution
Co-Organizer
Program Committee
- Ministry of Food and Drug Safety
- APEC Harmonization Center
- ECRI
- Japan Medical Imaging and Radiological Systems Industries
- Pharmaceuticals and Medical Devices Agency
- Dongguk University
- Roche
- University of Southern California
- Seoul Clinical Laboratories
- SEOUL NATIONAL UNIVERSITY
- UNIVERSITY OF YAMANASHI
- KOREA MEDICAL DEVICES INDUSTRY ASSOCIATION
- University of Ulsan