Advisory Committee on the Safety of Medicines (ACSOM)
14 October 2014
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.
The Therapeutic Goods Regulations make provision for the appointment of up to 25 persons, and fourteen 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.
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 epidemiology.
- Dr Liam Balkin is a staff specialist in the Department of Anaesthesia at the Princess Alexandra Hospital in Brisbane a senior lecturer for the Department of Anaesthesia and Critical Care at the University of Queensland. His major clinical and research interests include cardiac anaesthesia, trauma anaesthesia, transoesophageal echocardiography and transfusion medicine. Dr Balkin is the Queensland representative on the Australian and New Zealand College of Anaesthetists Trauma Special Interest Group (SIG) Committee and is a member of the Blood Products Advisory Committee for Queensland. Dr Balkin provides expertise in the field of anaesthetics.
- 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 and toxicology.
- Professor David Le Couteur is Professor of Geriatric Medicine at the University of Sydney, Director of the Centre for Education and Research on Ageing, Director of the Biogerontology Laboratory of the ANZAC Medical Research Institute and Senior Staff Specialist Physician in Geriatric Medicine at the Concord Repatriation General Hospital in Sydney. He has been a member of the Australian Drug Evaluation Committee, the Pharmaceutical Benefits Advisory Committee and president of the Australasian Society for Clinical and Experimental Pharmacologists and Toxicologists. Professor Le Couteur provides expertise in the fields of general medicine (geriatrics) and clinical pharmacology.
- Dr Genevieve Gabb is a senior staff specialist in general medicine at the Royal Adelaide Hospital and visiting medical officer at the Veterans Heart Clinic, Repatriation Hospital South Australia. She has extensive clinical experience in general and cardiovascular medicine and an interest in therapeutic drug safety. Dr Gabb is a member of the International Society for Pharmacoepidemiology, and is also a member of the Advisory Committee on Non-prescription Medicines. Dr Gabb provides expertise in the field of internal medicine.
- Dr Arnagretta Hunter is a cardiologist with broad clinical experience and a commitment to improving quality and safety in healthcare. Her specialist medical training was at St Vincent's Hospital, Darlinghurst, and St Vincent's Hospital, Fitzroy with some post-fellowship training at the Royal Melbourne Hospital. Dr Hunter worked in a busy clinical practice in Wagga Wagga in regional NSW from 2009 and in 2014 relocated to accept a position at Calvary Hospital in the Australian Capital Territory. Dr Hunter provides expertise in the field of cardiology.
- 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.
- Dr Mark Nicholls is a senior intensive care physician at St Vincent's Hospital, Darlinghurst and a senior lecturer at both the University of New South Wales and the University of Notre Dame, Sydney. Dr Nicholls has a particular interest in the intensive care management of trauma, mechanical assist devices and transplantation. Dr Nicholls provides expertise in the fields of intensive care and respiratory disease.
- 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 epidemiology and clinical pharmacy.
- 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. Associate Professor Smith provides expertise in the field of general medical practice.
- Dr Heather Tapp is a consultant paediatric haematologist/oncologist at the Women's and Children's Hospital, Adelaide and is also a senior adjunct lecturer at the University of South Australia. She is a Fellow of the Royal College of Pathologists of Australia and the Royal Australasian College of Physicians. Dr Tapp is a member of both the Australian and New Zealand Children's Haematology and Oncology Group and the US based Children's Oncology Group and collaborates with European Children's Oncology Study groups. Dr Tapp provides expertise in the fields of oncology, haematology and paediatrics.
- 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 endocrinology.
- Dr Michael Ward is a senior lecturer in the School of Pharmacy and Medical Sciences at the University of South Australia. Dr Ward is a pharmacist with research interests in a variety of factors that influence medication response including drug metabolism, drug-drug interactions, pharmacokinetics and pharmacogenetics. Dr Ward provides expertise in the field of clinical pharmacy.
ACSOM planned meeting dates 2014
|Meeting no.||Meeting date|
|21||7 March 2014|
|22||9 May 2014|
|23||11 July 2014|
|24||12 September 2014|
|25||7 November 2014|
To contact the ACSOM Secretariat:
|Telephone||+ 61 2 6232 8734|
|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
Content last updated: Tuesday, 14 October 2014
Content last reviewed: Tuesday, 14 October 2014
Web page last updated: Tuesday, 14 October 2014