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Advisory Committee on Medicines (ACM)

10 May 2022

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.

Membership

Chair

Associate Professor Geoffrey Herkes is a Senior Staff Specialist in Neurology, and previous Head of Department, 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. 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 served as Chair of the NSLHD Human Research Ethics Committee until 2022. He is also currently Health of the Division of Medicine, and Director of Research at the Sydney Adventist Hospital. He was awarded an AM in the 2022 Australia Day Awards. Associate Professor Herkes provides expertise in the field of neurology.

Members

Dr Kayte Evans is a General Practitioner at the Bullinah Aboriginal Health Service in Ballina NSW and is involved in rolling out Covid-19 vaccines. Dr Evans has worked in Aboriginal Health in NT, WA, and NSW for 31 years where she undertook annual assessments and reports on the public health and statistics of each remote community. In addition, she assisted in the introduction of measles vaccine in the early 1990’s and occasional cold chain failure and vaccine failure in these communities. Dr Evans has vast experience both within rural and urban Australian general practice, having worked extensively in the NT and QLD, as well as internationally as the Australian Embassy doctor in Cambodia. Dr Evans provides expertise in the field of general medical practice in Australia and infectious diseases.

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 laboratory 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. Dr Fletcher provides expertise in the field of paediatrics, genetics and inborn errors of metabolism.

Dr Joel Iedema is a clinical pharmacologist and endocrinologist. Dr Iedema has over a decade of experience in medicines governance with involvement in various medicines committees. He is the current deputy chair of the Queensland Health Medicines Advisory Committee. He maintains active clinical practice in endocrinology and general medicine. Dr Iedema provides expertise in the field of clinical pharmacology/pharmacokinetics and endocrinology.

Dr Debra Kennedy is the founder and current Director of Mothersafe, (the NSW Statewide Medications in Pregnancy and Lactation Advisory Service). She has 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 Robyn Langham is a nephrologist and general physician at Cabrini Hospital in Melbourne. A clinician researcher at the University of Melbourne with an interest in the development of anti-fibrotic medications, she is also a Director of the Australian Medical Council and is Chair of the HREC of the Royal Children's Hospital in Melbourne. Professor Langham provides expertise in the field of renal disease.

Dr Maya Latimer is a senior Consultant Haematologist at the Canberra Region Cancer Centre, Canberra Hospital. She is the current Chair of the ACT Health Multi-Disciplinary Team (MDT) for lymphoma, participates in the Leukaemia MDT and is one of the supervising haematologists for human genomics (cytogenetics and molecular haematology) at ACT Pathology. She is active in the Australasian Leukaemia and Lymphoma group, participating in the high grade lymphoma (NHL and Hodgkins), CLL, low grade lymphoma, CML and myeloproliferative neoplasm subgroups. Dr Latimer is also a member of the Australasian Lymphoma Alliance and the eviQ reference committee. Dr Latimer provides expertise in the field of internal medicine, particularly haematology.

Dr Bavahuna Manoharan is the State Clinical Director for the Covid-19 Vaccination Program in Queensland Health with oversight over the clinical aspects of the rollout and the Queensland Adverse Event Following Immunisation Program. He was previously the Deputy Director of Medical Services and Director of Obstetrics and Gynaecology at Logan Hospital, and has held similar medical administration roles. His area of specialty is medical administration and he has a specific interest and deep experience in clinical governance systems, patient safety & quality care, digital health, in particular better utilisation of digital health technologies for improved patient outcomes, population health chronic disease and oncological management and designing Value Based Health Care systems.He holds several key leadership roles including Vice President and Director of AMA Queensland and Director of the National Australian Medical Association. Dr Manoharan provides expertise in the field of epidemiology/biostatistics, radiology, medicines in pregnancy and medical ethics.

Professor Geoffrey McColl is Executive Dean of the Faculty of Medicine at the University of Queensland. He is a medical practitioner with a speciality qualification as a rheumatologist. Professor McColl brings considerable clinical and research experience in the areas of rheumatology and immunology. He was a member of the Pharmaceutical Benefits Advisory Committee and a previous Chair of its Drug Utilisation Sub-Committee. Professor McColl provides expertise in the field of rheumatology.

Ms Joanne Muller has been a consumer/community representative in the health sector since 1994. She holds formal qualifications in science, teaching, law and governance. Currently she sits on the NSW Nursing & Midwifery Council, the NSW Radiation Advisory Council, the National COVID-19 Clinical Evidence Taskforce's Consumer Panel, and the Nursing and Midwifery Strategic Reference Working Group. Her previous roles have included membership on the Therapeutic Guidelines group for Endocrinology, and on the ACSQHC's Venous Thromboembolism Prevention Clinical Care Standard Working Group. She has over 35 years as non-executive director roles in a wide variety of organisations and served six years as the legal member of the Cancer Council Ethics Committee (a Human Research Ethics Committees registered with NHMRC) and is an occasional lecturer on ethics and law for health students at two universities. Ms Muller provides expertise in consumer health issues.

Professor Michael Peek is Associate Dean (Health Precinct Planning) and Professor of Obstetrics and Gynaecology at the Australian National University. He is also a subspecialist in Maternal Fetal Medicine at the Centenary Hospital for Women & Children within Canberra Hospital & Health Services. His research interests are centred around medical disorders in pregnancy. Professor Peek was a previous Federal Council Member of the Royal Australian and New Zealand College of Obstetricians and Gynaecologists and a past President of the Australasian Society for the Study of Hypertension in Pregnancy. Professor Peek provides expertise in the field of medicines in pregnancy, obstetrics and gynaecology.

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 has actively participated on many committees, professional and public health organisations and was previously a member of the Australian Drug Evaluation Committee. 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.

Professor Philip Robinson is currently head of the Department of Respiratory and Sleep Medicine at the Royal Children's Hospital, in Melbourne. He also heads a drug trial research team at the Murdoch Children's Research Institute involving paediatric lung conditions. His main clinical interest is in suppurative lung disease, including CF and PCD as well as chronic lung disease of prematurity. Professor Robinson provides expertise in the field of respiratory disease.

Dr Susan Russell is a consultant paediatric haematologist/oncologist at Sydney Children’s Hospital (SCH) Randwick. Her experience includes management of children with leukaemia, lymphoma, solid tumours and those undergoing bone marrow transplantation. She is Head of the Haematology Programme and Director of the Haemophilia Treatment Centre at SCH. The programme manages children with bleeding disorders, thrombosis, haemoglobinopathies, and congenital and acquired bone marrow disorders. A recent focus of interest is the use of anticoagulants, novel agents and targeted therapies in the treatment of children with vascular anomalies and tumours. Dr Russell provides expertise in the field of paediatrics, haematology and oncology.

Clinical Associate Professor Rashmi Sharma has wide-ranging experience as a GP. She is a Clinical Associate Professor of General Practice at the Australian National University, a practicing GP and Regional Head of Education, North Coast, for the GP training provider, GP Synergy. Her interest in medicines commenced as an undergraduate when she completed a BSc in Clinical Pharmacology as part of her medical degree. She has an interest in quality systems relating to prescribing, dispensing and regulation of medicines. She works with the Royal Australian College of General Practitioners and other professional organisations on projects relating to QUM, application of medicines policies and inter-disciplinary teaching. Clinical Associate Professor Sharma chaired the Medicines Advisory Committee in the ACT and has extensive experience serving on government advisory boards, including as a member of the Pharmaceutical Benefits Advisory Committee. She is a current member of the Drug Utilisation Sub Committee. Clinical Associate Professor Sharma was awarded an OAM for her service to medicine, and provides expertise in the field of general medical practice in Australia.

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 and then the Director of Neurology at Gold Coast Hospital and Health Services. He recently assumed the role of Clinical Director of Diagnostic and Subspecialty Services at GCHHS. Throughout his career, he has taken on key advisory roles in clinical education in 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.

Professor Euan Walpole is currently the Medical Director for Cancer Services and Cancer Stream Leader at Princess Alexandra Hospital, Queensland. He is responsible for cancer clinical service delivery, safety, and financial outcome and research agendas. Other current positions held by Professor Walpole include honorary associate of NHMRC clinical trials centre, visiting medical officer at Mater Private hospital, ICON@South Brisbane and Brisbane Private Hospital and a pre-eminent medical specialist at Queensland Health. Professor Walpole provides expertise in the field of internal medicine, particularly medical oncology.

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 and currently serves as Chair of the Victorian Division of the Cardiac Society of Australia and New Zealand, as well as being the elected Victorian representative on the National CSANZ Board and a member of the CSANZ Quality and Standards Committee. Associate Professor Zentner provides expertise in the field of cardiology.

2022 ACM proposed meeting dates

Meeting no. Meeting dates
31 3-4 Feb 2022
32 1 April 2022
33 2-3 June 2022
34 4-5 August 2022
35 6-7 October 2022
36 1-2 December 2022

Contact details for the ACM

Medicines enquiries Committee support enquiries
Email acm@health.gov.au Committees@health.gov.au
Phone +61 2 6289 2915 or
+61 418 205 547
Postal Address Advisory Committee on Medicines
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606
Attn: Prescription Medicines Authorisation Branch, MDP 122
Committee Support Unit
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606
Attn: Scheduling & Committee Support Section, MDP 122