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SPECIAL NOTICE - 8 March, 2001

From March 5, 2001 to March 9, 2001 inclusive, meetings to effect transition of Chairmanship between Health Canada and Australia's Therapeutic Goods Administration were held in Canberra, Australia.

These meetings, which involved Ms. Beth Pieterson and Ms. Jocelyn Kula outgoing Chair and Secretariat respectively, and Ms. Rita Maclachlan and Mr. Craig Davies, incoming Chair and Secretariat, respectively, consisted of discussion on the following topics:

1. GHTF Website
Issues discussed included selection of a responsibility turn-over date and ongoing maintenance of the site including procedures and performance standards for posting documents, special notices, etc., and development of a private area on the site for Steering Committee business.

2. Finances
The Health Canada budget for the 8th Conference was discussed along with an explanation of Health Canada expenses related to the Chairmanship of GHTF and Conference-related costs borne by Health Canada or release of funds from the trust account established to accept registration fees for the 8th GHTF Conference and any sponsorship dollars received. Remaining funds from the Health Canada trust account were turned over to the TGA. The Canadian approach to sponsorship was also discussed.

3. ISO/TC 210
The history behind the signing of the MOU between ISO/TC 210 and GHTF was explained and Ms. Maclachlan was informed that she would be invited to attend the ISO/TC 210 Chair's Advisory Group meeting, as a representative of GHTF. The ongoing collaboration between ISO/TC 210 WG#1 and GHTF SG3, and between ISO/TC 210 WG#3 and GHTF regarding the Global Medical Device Nomenclature project's Policy Group was also discussed.

4. GHTF Document Template & Style Guide
Implementation of the template amongst the different Study Groups was discussed along with the role of the GHTF Secretariat in ensuring that principles laid out in the Style Guide are followed, e.g., reinforcement of the document numbering system described in the Operating Procedures document, use of the correct cover page, insertion of the copyright statement on final documents.

5. Study Group Business
The study group workplan template that had been used in the past was reviewed. There was general discussion regarding timeframes for responding to e-mails or documents received for further action. The existing system of correspondence files for each Study Group was reviewed and the role of the Secretariat in ensuring that the Study Group membership lists on file and posted on the website are current was also defined.

6. GHTF Documents
There was discussion regarding the posting of information pertaining to the implementation of all GHTF Final Documents by each founding member on the GHTF website and it was decided that the completed Australian templates for each founding member would be posted in entirety but also summary information would be added to the Study Group final document pages .

7. 9th GHTF Conference
Further to discussions at the first Steering Committee meeting, the proposed Conference programme was reviewed. Suitable speakers for the different social events were discussed as were the registration process, logistics (meeting room and audio-visual equipment), hotel accommodation and food arrangements. There was also discussion of the Conference fee, collection of registration fees and the establishment of a cancellation policy. It was established that Eucomed, in their role as host of the Global Medical Devices Conference would need to assist in making some of these arrangements.

Other items discussed throughout the week included:

1. GHTF Database
2. GHTF Correspondence
3. GHTF Logo
4. GHTF Files
5. Procedural Documents

Last Updated June 24, 2004