TGA international training calendar
Updated 17 December 2007
The information below provides details on the TGA International Training Calendar for 2008. Training programs are available for staff of overseas government regulatory organisations only.
TGA international training calendar for 2008
The following training activities are available for staff of overseas government regulatory organisations only. The programs will be presented at the Therapeutic Goods Administration (TGA), Canberra, Australia in 2008.
General conditions and requirements apply. Please refer to the 2008 TGA international training calendar - policy statement <http://www.tga.gov.au/international/trainpol.htm> for details.
Training program 1: Counterfeit medicine control and law enforcement
- Duration: 1 week
- Dates: Monday 31 March - Friday 4 April 2008
- Closing date for application: Wednesday 30 January 2008
- Features of the course: Trainees will be provided with up-to-date knowledge on the current internationally accepted best practice on counterfeit medicine control and law enforcement on medicine regulation.
- Who should attend: Officers of government regulatory agencies with responsibility for the investigation and prosecution of pharmaceutical crime including counterfeit medical products.
- Possible numbers of trainees: 6-12
- Training fees: $1,810 (GST* inclusive) per trainee
*GST - Australian Goods and Services Tax
Training program 2: Practical training in vaccine quality assurance
- Duration: 3 weeks
- Dates: Monday 5 - Friday 23 May 2008
- Closing date for application: Wednesday 5 March 2008
- Features of the course: Practical demonstrations, with some "hands on" work as appropriate, involving manufacture and QC aspects of product licensing, lot release, laboratory testing and the inter-relationship between these important regulatory techniques.
Specific topics/activities covered would include:- Product Licensing (Manufacture & QC aspects)
- Initial licensure (Dossier evaluation)
- Variations/updates
- Potency testing of vaccines
- Animal assays
- Immunological Assays [ELISA, SRID]
- Biochemical assays [Lowry, Orcinol]
- Live virus counts [Tissue culture]
- Live Bacterial counts
- Bacterial Endotoxin Test
- practical testing
- evaluation of company submissions for product licensing
- Lot release procedures
- Use of specifications agreed during product licensing
- Changes to product license/update of specifications
- Product Licensing (Manufacture & QC aspects)
- Who should attend: Regulatory agency staff with experience in regulation and quality control of vaccines. Qualifications and experience in biological science are required.
- Possible numbers of trainees: 2-3
- Training fees: $7,490 (GST* inclusive) per trainee
*GST - Australian Goods and Services Tax
Training program 3: Regulation of medical devices
- Duration: 1 week
- Dates: Monday 16 June - Friday 20 June 2008
- Closing date for application: Wednesday 30 April 2008
- Features of the course: The course will provide trainees with a practical understanding of Australia's risk-managed life cycle approach to medical device regulation. Australia's framework for regulation of medical devices is based on the principles and processes of the Global Harmonization Task Force (GHTF) on Medical Device Regulation.
Topics covered include:- clinical trial requirements;
- conformity assessments;
- the pre-market application process (electronic lodgment, the use of Global Medical Device Nomenclature (GMDN) codes, and the use of Summary Technical Document (STED) format for regulatory submissions);
- post-market activities (investigation of problem and adverse event reports, testing for compliance with standards, and post-market communication strategy); and
- advertising controls, enforcement and recalls.
A number of specific regulatory issues of interest to the international community will also be covered, including the following:
- Drug-device combination products;
- Regulation of Single Use Devices (SUDs); and
- Regulation of In Vitro Diagnostic Devices (IVDs).
The course consists of lectures with a practical focus, combined with interactive workshops and case studies.
- Who should attend: Regulatory agency staff involved in the regulation of medical devices. Basic knowledge and some experience in using the GHTF principles are desirable.
- Possible numbers of trainees: 7-15
- Training fees: $3,135 (GST* inclusive) per trainee
*GST - Australian Goods and Services Tax
Training program 4: Evaluation of generic medicines (covering active drug substance, finished drug products and bioequivalence data)
- Duration: 1 week
- Dates: Monday 21 - Friday 25 July 2008
- Closing date for application: Wednesday 21 May 2008
- Features of the course: The course is offered for participants with a particular interest in evaluation and regulation of generic medicines. It will include in depth lectures and practical workshops on how to assess all aspects of the manufacture, quality control, stability and bioequivalence data for generic medicines.
- Who should attend: Staff involved in the regulation of medicines. Basic knowledge and some experience in pharmaceutical chemistry, pharmaceutics and pharmacology or pharmacokinetics are essential.
- Possible numbers of trainees: 5-15
- Training fees: $2,696 (GST* inclusive) per trainee
*GST - Australian Goods and Services Tax
Training program 5: Regulation of complementary medicines (including traditional medicines, vitamin and mineral supplements)
- Duration: 1 week
- Dates: Monday 11 - Friday 15 August 2008
- Closing date: Wednesday 11 June 2008
- Features of the course: The program provides participants with a complete overview of Australian complementary medicines regulatory system, as well as practical demonstrations of the regulation of complementary medicines (including traditional medicines, vitamin and mineral supplements).
The program will include a description of the Listing and Registration process, the evaluation of substances for use in Listed medicines (including herbal preparations), the registration of higher risk complementary medicines, and a demonstration of the Electronic Listing Facility (ELF).
A workshop will be run allowing participants to experience the post market review of a low risk medicine, as well as the evaluation of either an individual ingredient or a discreet higher-risk finished product. - Who should attend: Regulatory agency staff involved in the regulation of complementary medicines.
- Possible numbers of trainees: 5-15
- Training fees: $3,060 (GST* inclusive) per trainee
*GST - Australian Goods and Services Tax
Training program 6: Medicinal products good manufacturing practice (GMP) training
- Duration: 1 week (in Canberra and Melbourne respectively)
- Dates: Monday 27 - Friday 31 October 2008
- Closing date: Wednesday 27 August 2008
- Features of the course: To provide workshop style and on site training in medicinal products GMP for auditors/inspectors.
- Who should attend: Regulatory agency staff who are current GMP auditors (inspectors) on medicinal products and have a good understanding of GMP audit with considerable working experience as GMP auditors/inspectors. Knowledge of pharmaceutical chemistry, microbiology and sterility is desirable.
- Possible numbers of trainees: 4-8
- Training fees: $3,260 (GST* inclusive) per trainee
(Local transport for site visit will be provided by the TGA)
*GST - Australian Goods and Services Tax
TGA international training activity application form
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