Advisory Committee on the Safety of Medicines (ACSOM)
3 May 2013
Role of ACSOM
The Advisory Committee on the Safety of Medicines (ACSOM) was formed in January 2010 to advise and make recommendations to the TGA on the:
- safety of medicines
- risk assessment and risk management of medicines
ACSOM may also provide advice to the TGA on other matters related to the detection, assessment, understanding and prevention of adverse effects, known as pharmacovigilance, and any other matters referred to it by the TGA.
ACSOM supersedes and expands upon the role of the Adverse Drug Reactions Advisory Committee (ADRAC) with an increased focus on the safety aspects of medicine regulation and the detection, assessment, understanding and prevention of adverse effects.
A major role for ACSOM is to provide advice on the quality and appropriateness of risk management plans which are designed to define and pro-actively manage risks relating to a medicine over its entire life cycle.
ACSOM membership
The Therapeutic Goods Regulations make provision for the appointment of up to 15 persons, and twelve members have been appointed to ACSOM. The membership includes experts in various fields relevant to medicines safety. Members are appointed on the basis of their individual skills, knowledge and expertise, not as representatives of any organisation.
Chairperson
Professor Emily Banks is a medically trained epidemiologist with interest and expertise in large cohort studies, pharmacoepidemiology, women's health, Aboriginal health and healthy ageing. She is currently the Head of Chronic Disease Epidemiology at the National Centre for Epidemiology and Population Health and is currently the Scientific Director of the 45 and Up Study. In 2000 she was awarded the UK National Woman of Achievement in Science and Technology. She has served as an advisor to the World Health Organization, and the International Agency for Research on Cancer. She chairs the External Scientific Advisory Committee for the Australian Longitudinal Study of Male Health and is a member of the Collaborative Group on Hormonal Factors in Breast Cancer, the Research Advisory Committee to the National Breast Cancer Foundation and the Drug Utilisation Sub-Committee of the Pharmaceutical Benefits Advisory Committee. Professor Banks provides expertise in the field of pharmacoepidemiology.
Members
- Professor Nicholas Buckley is a professor in medicine at the Prince of Wales Hospital Clinical School, University of NSW, a senior staff specialist (clinical academic) at Prince of Wales Hospital in clinical pharmacology and toxicology, and a senior staff specialist and consultant clinical toxicologist at the NSW Poisons Information Centre. He chairs the Editorial Advisory Board of the Australian Medicines Handbook. Professor Buckley has extensive experience in toxicology and provides expertise in the field of clinical pharmacology.
- Dr Michael Coory is a public-health physician and medical statistician at the Murdoch Children's Research Institute, and a clinical epidemiologist for the Victorian Department of Health. His main interests are in health policy; pharmaceutical regulation, subsidy and safety; and innovative uses of routine care-delivery data. Dr Coory provides expertise in the field of pharmacoepidemiology.
- Professor Stephen Kisely is a psychiatrist and public health physician with clinical and research experience in the UK, Australia and Canada. He is currently a psychiatrist at the Princess Alexandria Hospital in Brisbane, and a Professor and Director at Health LinQ at the University of Queensland. He also has experience in pharmacoepidemiology and biostatistics. Professor Kisely provides expertise in the field of general medicine (psychiatry).
- Associate Professor Peter Lewindon is a senior paediatric gastroenterologist and hepatologist at the Royal Children's Hospital, Brisbane, incorporating the Queensland Liver Transplant Service and the Paediatric Inflammatory Bowel Disease Service. He has a teaching position at the Department of Paediatrics, University of Queensland, and a visiting scientist position at the Hepatic Fibrosis Division, Queensland Institute of Medical Research. His major clinical and research interests include inflammatory bowel disease, mechanisms of hepatic fibrosis, liver transplantation and upper intestinal motility. Associate Professor Lewindon has experience in gastroenterology, and provides expertise in the fields of hepatology and paediatrics.
- Ms Alison Marcus has extensive understanding of consumer issues relating to quality use of medicines and medicine safety. Ms Marcus is a clinical nurse who has worked in a variety of settings within the health care system. These include, however are not limited to, renal and intensive care, midwifery, Aboriginal and aged care as well as working as a practice nurse in a semi rural general practice. Ms Marcus provides expertise in consumer issues.
- Mr Adam Phillips is an accredited pharmacist with a broad therapeutics background and active interests in adverse drug reaction reporting and patient safety in primary care. Mr Phillips provides expertise in the field of clinical pharmacy.
- Dr Nicole Pratt is a senior research fellow at the Quality Use of Medicines and Pharmacy Research Centre, Sansom Institute, University of South Australia. She is a member of the Australian Medicines Utilisation Research Australia Committee, a Co-coordinator & Co-Chair Elect, Asian Pharmacoepidemiology Network, and a Member of the Drug Utilisation Special Interest Group, International Society for Pharmacoepidemiology. Dr Pratt is a biostatistician and an active researcher in the area of medicine safety. Dr Pratt provides expertise in the field of phamacoepidemiology.
- Dr Gopala Rangan is a senior staff specialist in nephrology at Westmead Hospital, NSW, and a senior lecturer in medicine at the University of Sydney. Dr Rangan has extensive research and teaching experience, and over 20 years clinical experience in clinical medicine in public teaching hospitals. Dr Rangan provides expertise in the field of general medicine (nephrology).
- Dr Jane Robertson is a senior lecturer in the Department of Clinical Pharmaocology at the University of Newcastle. She is the Director of the Newcastle Evaluation Group, and the Director of the WHO Collaborating Centre for Pharmacoeconomics and Rational Pharmacotherapy. Dr Robertson is a pharmacist with experience in the evaluation of the efficacy and safety of medicines. Dr Robertson provides expertise in the fields of pharmacoepidemiology and clinical pharmacy.
- Associate Professor Peter Sexton is a general practitioner and public health physician, a clinical Associate Professor at the University of Tasmania, a professorial fellow at the Baker IDI Heart and Diabetes Institute and President of the National Heart Foundation. He chairs the Tasmanian Board of the Medical Board of Australia and is a past President of the Tasmanian Branch of the AMA. Associate Professor Sexton provides expertise in the field of general medical practice.
- Associate Professor Jane Smith is the head of general practice at Bond University, a member of the Centre for Research in Evidence Based Practice and works in clinical general practice. She teaches and researches in general practice, patient self-management and therapeutics. Associate Professor Smith is currently the Provost of the Royal Australian College of General Practitioners (RACGP) Queensland and has Vice-Chaired the RACGP Quality Care Committee, and co-authored the RACGP Guidelines for preventive activities in general practice. She is also a member of the Advisory Committee on Prescription Medicines (ACPM). Associate Professor Smith provides expertise in the field of general medical practice.
- Professor Duncan Topliss is Director of Endocrinology and Diabetes at the Alfred Hospital, and has clinical and research interests across endocrinology including diabetes, thyroid disease and bone disease. Professor Topliss has extensive experience in medical and scientific issues in the interests of drug regulation and is also a member of the TGA Advisory Committee on Prescription Medicines and was former Chair of the ACSOM's predecessor, the Adverse Drug Reaction Advisory Committee. Professor Topliss provides expertise in the field of general medicine (endocrinology).
ACSOM meeting dates
ACSOM meetings 2013
| Meeting no. | Meeting date |
|---|---|
| 16 | 8 March 2013 |
| 17 | 10 May 2013 |
| 18 | 12 July 2013 |
| 19 | 13 September 2013 |
| 20 | 8 November 2013 |
Contacting ACSOM
To contact the ACSOM Secretary:
| acsom@tga.gov.au | |
| Telephone | + 61 2 6232 8583 |
| Fax | + 61 2 6203 1250 |
| Postal address | Advisory Committee on the Safety of Medicines Office of Product Review Therapeutic Goods Administration PO Box 100 (MDP 122) Woden ACT 2606 Australia |
Reporting an adverse reaction to the Therapeutic Goods Administration
Content last updated: Friday, 3 May 2013
Content last reviewed: Friday, 3 May 2013
Web page last updated: Friday, 3 May 2013
URL: http://www.tga.gov.au/about/committees-acsom.htm