Medical Device is a highly regulated item. Technical requirement and regulation is changing rapidly. Many Asian countries are developing their regulatory system and more regulatory expertise is required. During the 2005 Global Harmonization Working Party (GHWP) meeting, members agreed the need to develop a systemic training program and Hong Kong industry was assigned to lead the project.
GHWP is seeking views and comments on the proposed Training Program
Background
Medical Device is a highly regulated item. Technical requirement and regulation is changing rapidly. Many Asian countries are developing their regulatory system and more regulatory expertise is required. During the 2005 Global Harmonization Working Party (GHWP) meeting, members agreed the need to develop a systemic training program and Hong Kong industry was assigned to lead the project.
The Training Proposal and Updates
Hong Kong Industry worked closely with GHWP Technical Committee (TC) to draft a proposal and presented during 2006 GHWP meeting in Korea. The amended proposal was also posted on GHWP websites for further comment and the responses are positive so far. Detail of the proposal can be found from the following link
http://www.asiahwp.org/index.php?page=article&id=215
In order to provide systemic support and for Hong Kong Industry (Mr. Jack Wong is the project leader) to develop the finalized training proposal, TC also formally formed a working group (WG06) with Mr. Albert Poon as the Chairman and Mr. Jack Wong as the vice-Chair to provide support for the training.
Training platform needs GHWP member economy representatives inputs
Representatives from two (2) universities are invited to present their training proposal for TC comment during last TC meeting on 27 April in Hong Kong. They are Northeastern University (NEU) from US and University of Hong Kong (HKU) from Hong Kong.
TC meeting participants provided a list of criteria for proposal selection. The criteria mentioned are
- regulatory knowledge of University
- reputation of University
- expense/investment require and revenue return
- ease of use of the on-line platform
- course development time
- independence
- intellectual property ownership for course content
A comparison table showing 2 universities inputs on the above 7 criteria was attached.
The GHWP TC now needs your attention to comment and make comparison between two universities based on criteria listed in the table. All feedbacks and comments should be filled in the table attached and should be submitted/emailed to Mr Jack Wong at jack.wong@bsi-global.com and cc to the GHWP Secretariat at ahwp@hkpc.org, before 31st July 2007.
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