NCCTG IVD working group
This committee is no longer operational. This information remains on this website as a historical reference only.
The National Co-ordinating Committee on Therapeutic Goods (NCCTG) IVD Working Group was established in January 2002, to assist in the development of a proposal for a new regulatory framework for IVDs.
Membership
| Chair | |
|---|---|
| Ms Rita Maclachlan | Therapeutic Goods Administration, Department of Health and Ageing |
| Members | |
| Mr Murray Patterson | Western Australia Department of Health |
| Ms Kim Stewart | New South Wales Health |
| Dr David Smith | Public Health Laboratory Network (PHLN) |
| Associate Professor Elizabeth Dax | National Serology Reference Laboratory (NRL) |
| Ms Margaret Arthur | Medical Industry Association of Australia (MIAA) |
| Mr Mike Ralston | Australian Association of Pathology Practices (AAPP) |
| Dr Robert Pritchard | Royal College of Pathologists of Australasia (RCPA) |
| Professor Leslie Burnett | Human Genetics Society of Australasia (HGSA) and National Pathology Accreditation Advisory Council (NPAAC) |
| Ms Fiona Brooke | Population Health Division, Department of Health and Ageing |
| Mr Damian Coburn | Diagnostics and Technology Branch, Acute Care Division, Department of Health and Ageing |
| Secretariat | |
| Ms Natalie Egan | Therapeutic Goods Administration, Department of Health and Ageing |
Meeting extracts
- Meeting 8: 22 October 2004
- Meeting 7: 16 September 2003
- Meeting 6: 1 July 2003
- Meeting 5: 8 November 2002
- Meeting 4: 3-4 July 2002
- Meeting 3: 17 April 2002
- Meeting 2: 27 March 2002
- Meeting 1: 21 February 2002
NCCTG IVD Working Group terms of reference
1. Purpose
To provide advice to the TGA regarding the development, supply and use of IVDs in Australia and to contribute to the development of a proposal for a regulatory framework for IVDs, that is in line with international best practice. The proposal will then be submitted for government consideration, following consideration by NCCTG and AHMAC.
2. Administrative arrangements
2.1 Meetings
It is projected that the Working Group may need to meet a minimum of three (3) times in order to carry out its purpose. All meetings will be located in Canberra, unless the Chair and all members agree on an alternate location.
Although it is hoped that members will endeavour to attend all meetings of the Working Group; members are encouraged to nominate an alternate in the instance should they be unable to attend a particular meeting.
Tele-conferences may be used as necessary to deal with specific issues which may arise between planned meetings.
2.2. Minutes
Meetings of the Working Group will not be recorded although notes will be taken on a laptop computer, and a meeting report (including action items) generated after each meeting.
2.4 Reporting
The Working Group will report to the Australian Health Minister's Advisory Council (AHMAC) via the National Coordinating Committee for Therapeutic Goods (NCCTG). The AHMAC Advisory Body on Human Genetic Testing will also be kept informed of Working Group progress.
Progress reports will also be submitted to Health Access and Financing Division (HAFD) and the Chair of the Therapeutic Devices Expert Committee (TDEC).