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About Workshop
The 2020 APEC Medical Devices Regulatory Science Center of Excellence Workshop focuses on training and education related to pre-market submission of medical devices. The concept of using essential principles to perform the conformity assessment of medical devices will be promoted. Through this workshop, it is expected that all member economies will gain a greater understanding of international best practices, learn to implement harmonized approaches, seek to facilitate regulatory convergence for medical devices within APEC economies, and this in turn may benefit the health and well-being of people in the Asia-Pacific region.
Target Audience
  • Regulators from APEC member economies and non-member economies
  • Industry managers (or equivalent position) who have experience in product application submission
  • Academic researchers or industry managers who have experience in product development
Venue
The workshop will be held virtually by online courses and videoconferences.
Videoconference Dates
September 4, September 8, September 9, and September 11, 2020.
Certificate Requirements
Each trainee is expected to complete 3 online courses and attend 3 videoconferences (including 1 videoconference on case study). The case study to attend will be assigned by CoE hosting institution. Certificates of participation will be mailed to qualified trainees that have met the following minimum requirements:
  • Completion of the total hours of all 3 online courses
  • Attendance of at least 2 videoconferences (including 1 on case study)
  • Completion of all questionnaires
Information Meeting for Enrollment
For those who are interested to participate in 2020 APEC Medical Devices Regulatory Science Center of Excellence Workshop, please attend the information meeting for enrollment of prospective trainees during registration period. This will be an online meeting held using WebEx to provide an overview of the training content and certificate requirements, as well as relevant information about the workshop.
Date and time: July 29, 2020, 06:00-07:00 GMT (Greenwich Mean Time)
Meeting link: https://reurl.cc/QdMl99
Meeting number (access code): 1668962601
Meeting password: emJgSYMY853
If attendance is possible, please sign up for the meeting at https://reurl.cc/lVrnnl
There is no registration fee for participating in the workshop.
CoE Hosting Institution
Taiwan Food and Drug Administration
Co-Organizer
The APEC LSIF Regulatory Harmonization Steering Committee
Program Committee
Pharmaceuticals and Medical Devices Agency
Japan Medical Imaging and Radiological Systems Industries
Advanced Medical Technology Association
Taiwan Medical and Biotech Industry Association
Taiwan Advanced Medical Technology Association
Industrial Technology Research Institute
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