Advisory Committee on the Safety of Medicines (ACSOM)

1 February 2016

Role of the 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 members


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.
  • 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.
  • Professor Stephen Kisely is a psychiatrist and public health physician with clinical and research experience in the United Kingdom, 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 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.
  • 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. His formal training was in clinical biochemistry and he has research interests in liver transplantation, cancer and clinical trials for the management of chronic wounds. Dr Lord's doctoral studies were done in conjunction with Dokkyo Medical University in Japan which gave him the opportunity to be involved in liver transplant programs. Dr Lord provides expertise in organ and tissue transplantation and infectious diseases.
  • 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 Nicole Pratt is a senior research fellow at the Quality Use of Medicines and Pharmacy Research Centre of the Sansom Institute at the University of South Australia. She is a member of the Australian Medicines Utilisation Research Australia Committee, a co-coordinator and co-Chair Elect of the Asian Pharmacoepidemiology Network, and a member of the Drug Utilisation Special Interest Group of the 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 biostatistics.
  • 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.
  • 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 meeting dates

ACSOM planned meeting dates 2016
Meeting no. Meeting date
31 19 February 2016
32 6 May 2016
33 1 July 2016
34 2 September 2016
35 18 November 2016

Contacting the ACSOM

To contact the ACSOM Secretariat:

ACSOM Secretariat contact details
Telephone + 61 2 6232 8734
Fax + 61 2 6203 1250
Postal address Advisory Committee on the Safety of Medicines
Therapeutic Goods Administration
PO Box 100
Woden ACT 2606

Reporting an adverse reaction to the Therapeutic Goods Administration