Therapeutic Goods Committee (TGC)

15 June 2015

Role of the TGC

The Therapeutic Goods Committee (TGC) is established under regulation 34 of the Therapeutic Goods Regulations 1990 (the regulations) to provide advice and to make recommendations to the Minister for Health on the adoption of standards for therapeutic goods, matters relating to standards for therapeutic goods, including requirements for labelling and packaging and standards for manufacture of therapeutic goods, and matters relating to medical device standards, conformity assessment standards and standards for biologicals.

For further details on the role and operation of the TGC, refer to the Therapeutic Goods Regulations 1990.

TGC members

Chair

Professor Andrew Somogyi is currently Professor in Clinical and Experimental Pharmacology at the Faculty of Health Sciences, University of Adelaide where he teaches basic and clinical pharmacology to medical, dental and nursing students. He is a member of the Editorial Advisory Committee of the Australian Medicines Handbook. He is also a registered and practicing pharmacist providing amongst other duties, patient medication counseling. He has extensive expertise in clinical pharmacology, pharmacogenetics, pharmacokinetics, drug metabolism and clinical trials. Professor Andrew Somogyi provides expertise in the field of pharmaceutical science.

Members

Mr Angelo Andronis is the General Manager, Technical of Integria Healthcare. He has over 25 years' experience in the complementary medicines manufacturing environment with past management roles at Herron Pharmaceuticals, Mayne/Symbion and Sanofi. Mr Angelo Andronis is the nominee of a body that represents the interests of Australian manufacturers of complementary medicines.

Dr Andrew Crowe is a senior lecturer in the School of Pharmacy, Curtin University and the Director of students and academic support within the school. His research interests include biometals, ADME and active efflux systems. Dr Andrew Crowe provides expertise in the field of pharmaceutical science.

Ms Mary Emanuel is a pharmacist with over 20 years' experience working in the non-prescription industry in areas relating to regulation and quality use of medicines and including scheduling, labelling and packaging, and provision of information to consumers. She has been a member of the TGA's Advisory Committee on Non-prescription Medicines and the Advisory Committee on Medicines Scheduling. Ms Mary Emanuel is the nominee of a body that represents the interests of Australian manufacturers of non-prescription medicine products.

Dr Alison Haywood is a Senior Lecturer at the School of Pharmacy, Griffith University and an Honorary Senior Research Fellow at Mater Medical Research Institute. Her research interest in personalised medicine and involvement in clinical research includes drug analysis, formulation and stability, pharmacometrics, pharmacogenomics and evidence based medicine. Dr Alison Haywood provides expertise in the field of pharmaceutical science.

Ms Debra Kay is currently a Guest Research Associate in Consumer Engagement at the University of South Australia and is an NPS Medicinewise Director. Ms Kay originally trained as a teacher and has undertaken health curriculum development, policy and research. She has worked with The Smith Family and was CEO of Asthma Australia. Ms Debra Kay is the nominee of a body that represents the interests of consumers of health services.

Dr Hanan Khalil is a pharmacist academic with Monash University and the Director of the Centre for Chronic Disease Management, an affiliated centre of the Joanna Briggs Institute specialising in evidence transfer and utilisation. She is also the Editor in Chief of the International Journal of Evidence-Based Healthcare. Dr Khalil has research interest in the areas of medication management, chronic diseases and evidence based health care in various health settings such as aged care, hospitals and community health services. Dr Hanan Khalil provides expertise in the field of community and hospital pharmacy practice.

Dr Roger Lord is a lecturer in Medical Sciences at the Australian Catholic University and a visiting research fellow attached to the Research and Practice Development Centre at The Prince Charles Hospital in Brisbane. He has research interests in liver transplantation, breast cancer and clinical trials for the management of chronic wounds. Dr Roger Lord provides expertise in the fields of microbiology and virology.

Mr Quentin McDonald is the Quality Assurance Manager for Novartis Pharmaceuticals. He has many years' experience in the pharmaceutical manufacturing industry with previous roles at Novogen Laboratories and AstraZeneca Australia. Mr Quentin McDonald is the nominee of a body that represents the interests of Australian manufacturers of prescription medicine products.

Ms Joyleen Winter is the Quality Manager of PlusLife (Perth Bone and Tissue Bank) and President of the Biotherapeutics Association of Australasia (BAA), the peak industry body for tissues and biotherapeutics in Australia. She has developed a risk management program for tissue banking and is involved in the development and maintenance of a range of guidance documents for tissue banking standards of practice. Ms Joyleen Winter is the nominee of a body that represents the interests of Australian manufacturers of medical devices and other therapeutic goods.

Contacting the TGC

To contact the TGC Secretary:

TGC Secretary contact details
Email TGC@tga.gov.au
Phone +61 2 6232 8852
Postal address Therapeutic Goods Committee
Therapeutic Goods Administration
PO Box 100
Woden ACT 2606
Australia