International training

In August 2001, four Indonesian officials received one week of training in medical device regulation. Funding was provided by AusAID's Government Sector Linkages Program (GSLP) with Indonesia and the World Health Organization (WHO).

During August/September 2001, a senior Indonesian official spent two weeks gaining an in-depth understanding of the management and corporate support activities conducted by the TGA. Funding was provided by AusAID's GSLP.

During September 2001, at the request of WHO, a senior Malaysian official received three weeks of training in therapeutic goods regulation.

Also during September 2001, three Vietnamese officials received two weeks of training in good laboratory practice. Funding was provided by WHO.

Senior TGA staff conducted the following training overseas on a cost-recovery basis:

• Kuala Lumpur: one week of analytical chemistry training during August 2001
• Hong Kong: one week of good manufacturing practice training during September 2001.

From 17 to 28 September 2001, the Drug Information Association* (DIA) and the TGA conducted the 2001 DIA-TGA Fellowship Program - Post-Market Vigilance of Therapeutic Goods. Funding was provided by the DIA and enabled participants from China, Indonesia, Malaysia, Singapore, Thailand and Vietnam to attend the two-week program. The program was designed for senior staff to assist them in gaining an increased understanding of all aspects of post-market vigilance for therapeutic goods.

*The DIA is a non-profit, multi-disciplinary, international scientific association.

International visitors

During August 2001, international delegations visiting the TGA included officials from the Shanghai Municipal Drug Administration, the United Arab Emirates, and the State Administration of Traditional Chinese Medicine in China.

ISO Technical Committee 150 - Implants for Surgery

In mid September 2001, the 19th meeting of the International Standards Organization (ISO) Technical Committee 150 (TC 150) - Implants for Surgery was convened by Standards Australia and hosted by the TGA.

Throughout the week, over seventy international visitors from fourteen countries, along with a number of TGA staff from the Conformity Assessment Branch and the Devices Program within TGA Laboratories, participated in two plenary sessions and eighteen working group meetings.

TC 150 and its subcommittees and working groups are supporting and developing standards for a very broad range of implantable medical devices, ranging from mechanical cardiac valves and prosthetic hips to cardiac pacemakers and neurological stimulators for the treatment of epilepsy and Parkinson's disease.

Global Harmonization Task Force (GHTF)

Recent activities

Australia, represented by the TGA, is the current Chair of the Global Harmonization Task Force (GHTF). The TGA is represented on the GHTF Steering Committee by Mr Terry Slater (National Manager) and Ms Rita Maclachlan (Director - Conformity Assessment Branch and GHTF Chair).

The second meeting of the GHTF Steering Committee was held in Brussels, Belgium, on 12-13 June 2001. During this meeting, the major issues considered by the Committee were:

• GHTF participation in the Global Medical Devices Nomenclature (GMDN) Maintenance Agency Policy Group;
• Development of the GHTF Strategic Plan (2002-2006);
• GHTF Study Group Work Plans;
• Approval of a Study Group 4 document as a "final document";
• New Chair for Study Group 2; and
• Retirement of Study Group 4 Chair, Mr Robert Allen.

Further details of these issues may be obtained from the "post-meeting statement" and the Meeting's minutes on the GHTF website: http://www.ghtf.org.

9th GHTF conference

In view of the recent tragic events in the USA, it is with great regret that a decision has been taken to postpone the 9th GHTF Conference, which was scheduled for 11-16 October 2001 in Barcelona, Spain.

As the GHTF Chair, Australia remains committed to still hosting the 9th GHTF Conference at some stage prior to the end of its term on 30 June 2002 and have opened discussions to reinstate the event in May - early June 2002. Further announcements on this will be made at an appropriate time in the future.

For delegates who have already registered for one or both conferences, please note that IBC Global Conferences Ltd will be in contact about refunds as soon as possible.

Asian Harmonisation Working Party (AHWP) Technical Committee meeting and workshop

On 6-7 September 2001, the GHTF Chair, Rita Maclachlan delivered the keynote speech at the AHWP Technical Committee Meeting and Workshop in Kuala Lumpur, Malaysia.

The AHWP has continued to maintain a high profile in the field of international harmonisation and the Technical Committee meeting provided a forum to discuss pertinent issues and regional commitment towards greater harmonisation of medical device regulations. The Workshop then provided training on various GHTF guidance documents that have been developed by the GHTF Study Groups.