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Advisory Committee on Medicines (ACM)

27 November 2019

Role of the ACM

The ACM provides independent medical and scientific advice to the Minister for Health and the Therapeutic Goods Administration (TGA) on issues relating to the safety, quality and efficacy of medicines supplied in Australia including issues relating to pre-market and post-market functions for medicines.

The Committee is established under Regulation 35 of the Therapeutic Goods Regulations 1990. Members are appointed by the Minister.

The ACM was established in January 2017, to encompass pre and post-market advice for medicines, following the consolidation of the previous functions of the Advisory Committee on Prescription Medicines (ACPM), the Advisory Committee on the Safety of Medicines (ACSOM) and the Advisory Committee on Non-Prescription Medicines (ACNM).

Membership comprises of professionals with specific scientific, medical or clinical expertise, as well as appropriate consumer health issues relating to medicines.



Associate Professor Geoffrey Herkes is a Senior Staff Specialist in Neurology at the Royal North Shore Hospital in Sydney and Clinical Associate Professor of Medicine at the University of Sydney. He has a long interest in medicine regulation and safety and was the last chair of ADEC (2008-2009), first chair of ACPM (from 2010), and served with the TGA as a committee member from 1999. Associate Professor Herkes conducts research in neuropharmacology and epilepsy, and works at the Royal North Shore Hospital, where he was Head of the Department of Neurology from 2008 to 2013. In 2016, he was awarded the ANZAN (Australian and New Zealand Association of Neurology) medal for outstanding service to neurology nationally and internationally. He also serves as Chair of the NSLHD Human Research Ethics Committee. Associate Professor Herkes provides expertise in the field of neurology.


Dr Janice Fletcher is a paediatrician, biochemical geneticist and genetic pathologist. She is the current Clinical Director of Genetics and Molecular Pathology, responsible for the provision of both laboratory and clinical genetics services for South Australia. She is the pathologist responsible for the South Australian Newborn Screening Service and the National Referral Laboratory for the Diagnosis of Lysosomal and Peroxisomal disorders. She is also the Deputy Director for SA Pathology and the current President of the AMA (South Australia). Dr Fletcher provides expertise in the field of paediatrics.

Dr Marion Kainer is an infectious diseases physician and epidemiologist. She has been the Director of the Healthcare Associated Infections and Antimicrobial Resistance Program at the Tennessee Department of Health and an Assistant Clinical Professor of Health Policy at Vanderbilt University School of Medicine since 2003. She obtained her medical degree at the University of Melbourne, a Master of Public Health from Monash University and trained in infectious diseases at Fairfield Hospital and the Austin Repatriation Medical Center. She served as an Epidemic Intelligence Service Officer (EISO) at the Centers for Disease Control and Prevention (CDC) in Atlanta. Dr Kainer provides expertise in the field of infectious diseases and antimicrobial resistance.

Professor Stewart J Kellie is a full-time paediatric oncologist and neuro-oncologist at the Children's Hospital at Westmead, Sydney, and Clinical Professor in the Discipline of Child and Adolescent Health at the University of Sydney. He received a Doctorate of Medicine in 2005 for his thesis titled "Advances in Paediatric Neuro-Oncology" from the University of Sydney. Professor Kellie was the chairman of the University of Sydney Human Research Ethics Committee from 2001-2004, and was the Chairman of the 16th International Symposium on Pediatric Neuro-Oncology (ISPNO) hosted in Singapore in early July 2014. Professor Kellie provides expertise in the field of oncology.

Dr Debra Kennedy is the founder and current Director of Mothersafe, (the NSW Statewide Medications in Pregnancy and Lactation Advisory Service). She has a background in the areas of clinical teratology and pharmacology as well as paediatrics and clinical genetics. Dr Kennedy provides expertise in the field of medicines in pregnancy.

Professor Steve Kisely is trained in psychiatry, public health and addiction medicine. He is a professor at the University of Queensland. He has previously been on the Therapeutic Goods Administration's Psychiatric Drug Safety Expert Advisory Panel (2008-2009) and Advisory Committee on the Safety of Medicines (2011-2016). Professor Kisely provides expertise in the field of psychiatry.

Professor Robyn Langham is the Head of the School of Rural Health at Monash University. As a practising nephrologist and general physician, she has a broad understanding of the effects of most medicines in the clinical setting. Her expertise in renal disease, transplantation, immunology, endocrinology and cardiovascular disease has been developed over twenty years of public hospital nephrology practice, the majority as head of a busy metropolitan renal unit in Melbourne. Professor Langham also has extensive experience in the biotech industry, particularly drug development, pharmacokinetics and drug manufacture. Professor Langham provides expertise in the field of renal disease.

Dr Liang Joo Leow is a Conjoint Senior Lecturer at the Department of Clinical Pharmacology and Toxicology, St Vincent's Hospital, Sydney; and at the University of New South Wales. He is a fellow of the Australasian College of Dermatologists and the American College of Mohs Surgery, and a Graduate of the Australian Institute of Company Directors. He holds a Master of Public Health and Tropical Medicine, and with an active interest in clinical governance, serves on company boards and committees in the health sector. Dr Leow provides expertise in the field of dermatology.

Ms Alison Marcus has been actively involved in representing health consumers' interests since 2003, and was a member of the Advisory Committee on the Safety of Medicines. She is involved in community organisations in Adelaide and is interested in fostering opportunities for consumers and carers to improve health literacy, and ensuring that information is credible and readily available. She is a registered Nurse who has worked in metropolitan, regional and remote health services in the public and private sectors, and in a range of community health and tertiary specialty clinical areas. Ms Marcus provides expertise in the field of consumer health issues.

Professor Geoffrey McColl is Head of the Melbourne Medical School and Professor of Medical Education and Training at the University of Melbourne. He is a medical practitioner with a speciality qualification as a rheumatologist. He is also a consultant rheumatologist at the Royal Melbourne Hospital. Professor McColl brings considerable clinical experience in the areas of rheumatology and immunology practice and research. He has been a member of the Pharmaceutical Benefits Advisory Committee for 12 years and more recently was appointed Chair of the Drug Utilisation Sub-Committee. Professor McColl provides expertise in the field of rheumatology.

Associate Professor Wendy Munckhof is an infectious diseases physician and clinical microbiologist at the Gold Coast University Hospital and Wesley Hospital, Brisbane and an Associate Professor in the Department of Medicine, University of Queensland. She has a PhD in antimicrobial pharmacodynamics. Her research interests are antimicrobial pharmacodynamics, antimicrobial stewardship and the epidemiology and management of Staphylococcus aureus infections. She has previously been Secretary of the Australian Society for Antimicrobials, Councillor of the Australasian Society for Infectious Diseases, and a member of the expert writing group for Therapeutic Guidelines: Antibiotic. Associate Professor Munckhof provides expertise in the fields of infectious diseases, clinical microbiology and antimicrobial therapy.

Dr Emma Palfreyman is a consultant haematologist at the Canberra Hospital and ACT Pathology, and is the Deputy Director of the Bone Marrow Transplantation Unit. She finalised her training in Vancouver, Canada in BMT and Leukaemia, and is currently enrolled with the European School of Oncology in further studies of lymphoma. She has a special interest in leukaemia, lymphoma and stem cell transplantation, but also works as a general haematologist. Dr Palfreyman provides expertise in the field of haematology.

Dr Stephen Phillips OAM is a General Practitioner with a long interest in standards and quality, particularly in relation to medicines, therapeutics and public health. Dr Phillips actively participates on a variety of committees and medical professional organisations and was previously a member of the Advisory Committee on Prescription Medicines. He was awarded the Medal of the Order of Australia for his services as a promoter of the safe and effective use of medicines. Dr Phillips provides expertise in the field of general medical practice in Australia.

Associate Professor Peter Pillans is a specialist in clinical pharmacology, Associate Professor in the Department of Medicine, University of Queensland and currently the Director of Clinical Pharmacology and a specialist physician at Princess Alexandra Hospital. He has a particular interest in drug safety, and served on the New Zealand Medicines Adverse Reactions Committee and the Australian Adverse Drug Reactions Advisory Committee for many years. He was previously a member of Advisory Committee on Prescription Medicines. He chairs numerous hospital drug committees and is deputy chair of the Queensland Hospitals Medicines Advisory Committee. Associate Professor Pillans provides expertise in the field of clinical pharmacology or pharmacokinetics.

Dr Lynne Rainey trained initially as a paediatrician, then later in anaesthesia, with an interest in paediatrics. From 1999 to 2011, Dr Rainey was a specialist anaesthetist at Flinders Medical Centre, and has worked in private practice since 2006. She recently retired from clinical anaesthesia. Dr Rainey maintains an ongoing interest in medical education, and was a final examiner for ANZCA for 12 years. She has been a board member of the SA Medical Board of Australia since 2011. Dr Rainey provides expertise in the field of anaesthetics.

Associate Professor Alice Richardson is a biostatistician at the National Centre for Epidemiology & Population Health, Research School of Population Health, Australian National University. She taught undergraduate statistics for two decades at the University of Canberra, and collaborated on a variety of quantitative research projects. Her research interests are in linear models; robust statistics; statistical properties of data mining methods; statistical methods applied to large data sets in biomedical sciences; and statistics education. Dr Richardson provides expertise in the field of biostatistics.

Professor Philip Robinson is a specialist paediatric respiratory physician at the Royal Children's Hospital, Victoria and Head of the hospital's Cystic Fibrosis Service. He helped establish the Royal Children's Cystic Fibrosis Research Trust and remains the Trust's medical chair. Associate Professor Robinson provides expertise in the field of respiratory disease.

Dr Kee Meng Tan completed his neurology training at Royal Brisbane & Women's Hospital and the Mayo Clinic, Rochester, with fellowships in Clinical Neurophysiology and Autoimmune Neurology. He joined the Comprehensive Epilepsy Program at Royal Melbourne Hospital in 2008, before returning to Queensland in 2017 as Director of Neurology at Gold Coast University Hospital. He pursues a keen interest in clinical education through hospitals, medical schools and the Royal Australasian College of Physicians. Dr Tan provides expertise in the field of neurology.

Professor Duncan Topliss is the Director, Department of Endocrinology and Diabetes at the Alfred, Melbourne, and Professor of Medicine, Monash University. He is a past President and Life Member of the Endocrine Society of Australia. He has a wide expertise in clinical endocrinology including thyroid disease, diabetes, osteoporosis, pituitary and adrenal disease, and endocrine hypertension. Professor Topliss provides expertise in the field of endocrinology.

Associate Professor Dominica Zentner is an adult cardiologist at the Royal Melbourne Hospital with a PhD on cardiac changes during normal human pregnancy. Her clinical practice encompasses general clinical cardiology, adult congenital heart disease, the management of women with cardiac disease during pregnancy, genetic cardiology and echocardiography. She is involved in clinical research in these areas. Associate Professor Zentner provides expertise in the field of cardiology.

2019-2020 ACM proposed meeting dates

Meeting no. Cut-off date for pre-ACM response Meeting dates
18 19 November 2019 5-6 December 2019
19 21 January 2020 6-7 February 2020
20 17 March 2020 2-3 April 2020
21 19 May 2020 4-5 June 2020
22 21 July 2020 6-7 August 2020
23 15 September 2020 1-2 October 2020
24 17 November 2020 3-4 December 2020

Contact details for the ACM

Phone +61 2 6232 8665
Mobile +61 468 609 842
Fax +61 2 6203 1250
Postal Address Advisory Committee on Medicines
Therapeutic Goods Administration
PO Box 100
Attn: Scheduling & Committee Support Section, MDP 122