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 thirteen 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 has internationally recognised and respected expertise in pharmacoepidemiology and extensive experience in quantitative evaluation of the risks and benefits of medicines.
Members
- Associate Professor Christopher Beer provides expertise in the fields of geriatric medicine and clinical pharmacology.
- Professor Nicholas Buckley has extensive experience and recognised expertise in clinical pharmacology and toxicology.
- Associate Professor Wendyl D'Souza is a neurologist with experience in clinical epidemiology and public health research.
- Professor Stephen Kisely provides expertise in the field of psychiatry, pharmacoepidemiology and biostatistics.
- Associate Professor Kristine Macartney is a paediatric immunologist and infectious diseases specialist with particular expertise in the field of vaccine safety.
- Ms Alison Marcus has extensive understanding of consumer issues relating to quality use of medicines and medicine safety.
- Mr Adam Phillips is a clinical pharmacist with experience in developing reporting systems for adverse drug reactions.
- Dr Nicole Pratt is a biostatistician and an active researcher in the area of medicine safety.
- Dr Gopala Rangan is a nephrologist with extensive research and teaching experience.
- Associate Professor Jane Robertson is a pharmacist with extensive expertise in pharmacy and pharmacoepidemiology.
- Dr Jane Smith provides expertise in the fields of general practice and medical education.
- Professor Duncan Topliss provides expertise in endocrinology together with a long-established record of providing advice to the Australian Government on matters of medicine safety. He is a member of the Advisory Committee on Prescription Medicines and was a former Chair of ADRAC.
ACSOM meeting dates
ACSOM meetings 2012
| Meeting no. | Meeting date |
|---|---|
| 11 | 24 February 2012 |
| 12 | 11 May 2012 |
| 13 | 6 July 2012 |
| 14 | 14 September 2012 |
| 15 | 9 November 2012 |
Contacting ACSOM
To contact the ACSOM Secretary:
| acsom@tga.gov.au | |
| Telephone | 02 6232 8583 |
| Postal address | The Secretary Advisory Committee on the Safety of Medicines Office of Product Review Therapeutic Goods Administration PO Box 100 Woden ACT 2606 |
Reporting an adverse reaction to the Therapeutic Goods Administration
- Which reactions to report
- What information to include in a report
- How to report an adverse drug reaction
- What happens to a report
- Guidelines for sponsors
For details Click here
