Dr Elaine Walker

Dr Elaine Walker

Dr Elaine Walker was appointed as Director of the TGA Laboratories Branch (TGAL) in March 1997.

Dr Walker, a graduate in Biochemistry obtained a PhD in protein chemistry from Sydney University before undertaking teaching and research in universities and hospitals in Australia and Scotland. Application of training in enzymology to research in cardiology and autoimmunity increased her interest in the quality of drugs and the development of diagnostic kits.

Dr Walker joined the Pharmacology Section of NBSL in 1987 to maintain sampling and research activities as the Section became involved in the premarket evaluation of a wide range of recombinant products and plasma derivatives. She became Head of the Molecular Biology Section in 1992 and Acting Director of TGAL in July 1996.

In recent years responsibilities of TGA have diversified to include the registration of herbal and other complementary medicines, disinfectants, biotechnology and gene therapy products as well as the more traditional pharmaceutical and device product base. TGAL's contribution to this regulation includes premarket evaluation and post marketing surveillance of therapeutic goods, providing specialist advice to industry and expertise in specialist areas in GMP audits as well as the development of standards. Applying a level of regulation appropriate to the varying risks of such a diverse range of products continues to be a major challenge to TGAL.

Ngaire Bryan

Ngaire Bryan

Although a relative newcomer to the TGA, Ngaire Bryan has had an extensive career in the Commonwealth public sector. Ngaire's professional interest has been in public sector administration with a particular emphasis on personnel management and industrial relations and she has worked in many senior positions providing high level advice in these areas. As Director Personnel in the Department of Health and Family Services from May 1991, Ngaire was instrumental in developing many of the procedures and policies still relevant today. Her work in the public sector has seen her involved in a wide range of issues of concern to both managers and staff including the restructuring of the Department of Defence factories and naval dockyards in the 1980s.

Ngaire joined the TGA in April 1996 as Head of the Coordination Unit Drug Safety and Evaluation Branch. In August of the same year she moved to her current position where she is responsible for managing the corporate activities of the TGA including financial, personnel and information technology services as well as monitoring compliance with TGA legislation. In addition, Ngaire has responsibility for ensuring that the TGA maintains a strategic and business focus in implementing government policies relating to the regulation of therapeutic products.

The coming year presents many challenges for the Business and Services Branch particularly in light of the Government decision earlier this year to increase the industry contribution towards the cost of regulation of therapeutic products. Ngaire believes it will be important to improve the management and flow of information within the TGA and to look for ways to further improve efficiency and work practices without unreasonably compromising the TGA's capacity to fulfil its statutory obligations. She said it is also important to provide improved access for industry and consumers to information on the role and responsibilities of the TGA and the requirements of the therapeutic goods legislation.