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Working Towards Harmonization
in Medical Device Regulation
in Medical Device Regulation
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Working Towards Harmonization in Medical Device Regulation |
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| GHTF > Meetings and Training > Conferences > 5th APEC-Funded Seminar on
Harmonization of Medical Device Regulations |
Health Canada, together with MEDICAL DEVICES CANADA (MEDEC), the Latin American Harmonization Working Party (LAHWP), the Pan American Health Organization (PAHO), the Asian Harmonization Working Party (AHWP), and the U.S. Department of Commerce, presents the latest in the series of seminars educating regulators and industry professionals on global harmonization of medical device regulation. Participation in the seminar will help you as a regulator, an industry regulatory professional, a representative of a conformity assessment body (CAB), or a distributor of medical devices, better understand global medical device regulations and the emerging similarities between them. There will be significant business and private sector cooperation in the seminar. Major medical device industry associations in many APEC economies support the event, and representatives from several of these organizations serve on the Seminar Planning Committee. Government and private sector regulatory experts from the medical device Global Harmonization Task Force (GHTF) Study Groups will serve as faculty for the seminar, further broadening your educational progress.
The focus of the seminar will be GHTF Study Groups (involving SG1, SG2, SG3, SG4 and SG 5), with a concentration on how GHTF founding member economies deal with regulatory, auditing, quality system and surveillance issues. Case studies will be used as a learning tool. For example, a case study may be developed on how to handle the problem of a medical device failure in the marketplace, and how regulators and industry work together to resolve the problem. Another focus of the seminar will be the roles of regulators, industry, and distributors to ensure a secure medical devices supply chain.
While this seminar is an APEC funded seminar primarily for APEC economies, APEC has authorized the following non-APEC economies to attend - Argentina, Brazil, Bolivia, Colombia, Costa Rica, El Salvador, Honduras, Nicaragua, Panama, Uruguay, Cambodia, India, and Laos. The seminar’s trainers will make presentations, participate in panel discussions, lead group discussions and present case studies. A new feature of this training will build on the experience of regulators who have attended previous seminars.
Who should attend the Seminar?
Representatives from:
- APEC member economies with established or developing medical regulatory systems
- Non APEC member economies with established or developing medical regulatory systems
(APEC has authorized limited non-APEC regulators participation from the following economies Argentina, Brazil, Bolivia, Colombia, Costa Rica, El Salvador, Honduras, Nicaragua, Panama, Uruguay, Cambodia, India, and Laos)- Regulatory affairs professionals working in regulatory agencies or for medical devices industry
- Medical device distributors or conformity assessment bodies (CABs)
Seminar’s objectives:
- Understanding GHTF recommendations on issues relating to regulation, auditing, quality systems and surveillance
- Practical training sessions achieved through a smaller instructor to student ratio, using case studies and interactive discussion between instructors and students
- Providing guidance on the role of regulators, industry, and distributors in regulatory harmonization and securing the integrity of the medical devices supply chain
There are limited funds available for travel subsidies (the cost of round trip economy-class airfare, lodging, and per diem costs) for government representatives from the following APEC economies: Mexico, Chile, Peru, China, Indonesia, Malaysia, Papua New Guinea, Philippines, Russia, Thailand and Viet Nam. If you are a government official from one of these economies and you wish to be considered for the travel support available, please send an e-mail to Gerry Zapiain at Gerry.Zapiain@mail.doc.gov and Jeffrey Gren at Jeffrey.Gren@mail.doc.gov. Please include your name, position, agency or ministry, full contact information, and a short narrative on why you and your economy would benefit from your participation in the APEC seminar. We will need this e-mail submitted no later than March 31, 2009. You will be notified if you are selected for the travel support by April 15, 2009.
Updated 7 May 2009
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