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Advisory Committee on Prescription Medicines (ACPM)

3 May 2013

Role of ACPM

The Advisory Committee on Prescription Medicines (ACPM) was formed in January 2010. The ACPM advises and makes recommendations to the TGA on prescription medicines. This includes:

• inclusion of a prescription medicine on the Australian Register of Therapeutic Goods (the Register)
• changes to an entry of a prescription medicine on the Register
• removal or retention of a prescription medicine on the Register.

ACPM may also provide advice to the Minister or the Secretary, through the TGA on other matters concerning a prescription medicine, and any other matters referred to it by the Minister or the Secretary.

The ACPM is the successor of the Australian Drug Evaluation Committee (ADEC), which was formed in 1963.

Advisory Committee on Prescription Medicines (ACPM) members

Chair

Clinical Associate Professor Geoffrey Herkes is Head of Department of Neurology, Royal North Shore Hospital Sydney, and holds a teaching position at the University of Sydney. He has major research interests in neuropharmacology and epilepsy, as well as in general neurology. He attained his PhD at the University of Queensland and studied at the Mayo Clinic, USA. Associate Professor Herkes has held executive positions on many research and clinical associations and bodies within Australia. He has been a member of ACPM since 1999, and was appointed Chair in 2008. Associate Professor Herkes provides expertise in the field of neurology.

Members

• Dr Barbara-Ann Adelstein is a Senior Lecturer in Medicine at the Prince of Wales Clinical School, University of NSW. She is a medical practitioner with a broad clinical background, a PhD in epidemiology and experience in medical and health services research. Her interests include improving health outcomes, providing effective health care and using research expertise and evidence-based practice to improve clinical care. Dr Adelstein provides expertise in the field of epidemiology.
• Ms Kathryn Briant has wide-ranging experience in the health sector including pharmaceutical policy and medication safety. She has particular interests in the Quality Use of Medicines and consumer participation. She has worked previously in the Department of Health and Ageing and for Divisions of General Practice. She is currently a consultant with the consumer health movement. Ms Briant provides expertise in the field of consumer issues.
• Associate Professor Shane Carney is a nephrologist at John Hunter Hospital and a clinical academic in the Faculty of Medicine and Health Sciences at the University of Newcastle. He has clinical pharmacology expertise in nephrology including transplantation and hypertension. Associate Professor Carney provides expertise in the field of renal disease.
• Associate Professor Allen Cheng is an infectious diseases physician at the Alfred Hospital and Associate Chair in Infectious Diseases Epidemiology at the Department of Epidemiology and Preventative Medicine at Monash University. Dr Cheng has diverse clinical experience in metropolitan and regional hospitals in Australia, research interests in clinical infectious diseases, infection control and public health epidemiology. Associate Professor Cheng provides expertise in the fields of infectious diseases and biostatistics.
• Professor Stephen Clarke is an oncologist and senior staff specialist in Medical Oncology and Professor of Medicine at the Royal North Shore Hospital and the University of Sydney. Professor Clarke has research interests in cancer pharmacology, colorectal cancer and lung cancer. Professor Clarke provides expertise in the fields of oncology and pharmacology.
• Dr Alison Davis is a senior staff specialist in medical oncology at the Canberra Hospital, and senior lecturer in medical oncology at the Australian National University's medical School. She is actively involved in clinical research with a sub-speciality interest in breast and gynaecological malignancies. Dr Davis provides expertise in the field of oncology.
• Ms Janne D Graham AM has extensive experience in recognising consumer concerns through involvement in the organised consumer movement. She has represented these interests through the development of the National Medicine Policy and advocacy on a range of medicine and other issues at government, professional and industry forums nationally and internationally. Ms Graham holds an honorary membership on the not for profit organisation, the National Prescribing Service. For her work in this area she has been recognised with an award of a Member of the Order of Australia. Ms Graham provides expertise in the field of consumer issues.
• Dr Richard Halliwell is the Director of the Acute Pain Service, Westmead Hospital, Deputy Director of the Anaesthesia Department Westmead Hospital, Chair of Westmead Hospital Safe Use of Medicines Committee, Deputy Chair of the Western Sydney Local Health District Drug Committee and a Clinical Senior Lecturer, Sydney Medical School, University of Sydney. He also has experience and interest in clinical pharmacology and clinical trials. Dr Halliwell provides expertise in general and regional anaesthesia and pain management.
• Associate Professor Jane Hanrahan is a medicinal chemist in the Faculty of Pharmacy at the University of Sydney. Her research interests currently include the medicinal chemistry and pharmacology of neurologically active drugs and the isolation and identification of natural products with neurological and anti-cancer activities. Associate Professor Hanrahan provides expertise in the field of pharmaceutical chemistry.
• Associate Professor Catherine Hill is a consultant rheumatologist at the Queen Elizabeth Hospital in Adelaide and holds a teaching and research position in medicine at the University of Adelaide. Associate Professor Hill has extensive experience in clinical trials, holds a Master of Science degree majoring in epidemiology from Boston University, USA and an MD from the University of Adelaide. Her current research interests are in the epidemiology of musculoskeletal disorders, clinical trial methodology, osteoarthritis and temporal arthritis. Associate Professor Hill provides expertise in rheumatology.
• Emeritus Professor Gordon Johnson is Emeritus Professor of Psychiatry, University of Sydney and former Director, Mood Disorders Unit, Northside Clinic, Sydney. Professor Johnson has clinical and research interests in psychopharmacology and mood disorders. He was a member of the Pharmaceutical Benefits Advisory Committee 1994-2000. Emeritus Professor Johnson provides expertise in the field of psychiatry.
• Professor Stewart Kellie is a paediatric oncologist at The Children's Hospital, Westmead and Clinical Professor in the Discipline of Paediatrics and Child Health at the University of Sydney. He has a particular interest in neuro-oncology in infants and children and has an MD for his thesis titled ‘Advances in Paediatric Neuro-Oncology’. He has an ongoing interest in training fellows from developing countries. Professor Kellie provides expertise in the fields of oncology and paediatrics.
• Dr Debra Kennedy is a Paediatrician and Clinical Geneticist. She established and is the Director of MotherSafe which is a statewide NSW service that provides evidence-based advice and counselling to both consumers and health care providers regarding medication and other exposures during pregnancy and breast feeding. Dr Kennedy is involved in clinical practice and research as well as being a conjoint lecturer in the School of Women's and Children's Health at UNSW. Dr Kennedy provides expertise in the field of paediatrics.
• Professor Harry McConnell is a neuropsychiatrist with specific expertise in neurodisability and epilepsy, with broad international experience. Professor McConnell is currently Director of Neurosciences at St Vincent's Hospital Brisbane and the Clinical Subdean at Gold Coast University Hospital and Griffith University School of Medicine where he is also Professor of Neuropsychiatry and Neurodisability. He is Chair of the South East Queensland Disability Advisory Council and a member of the Queensland Disability Advisory Council. Professor McConnell provides expertise in the field of psychiatry.
• Associate Professor Anne Mijch OAM is a consultant infectious diseases specialist with special interest in HIV, STIs and Hepatitis. She established HIV services at Fairfield Infectious Diseases Hospital then transferred these to Alfred Hospital in Melbourne. Associate Professor Mijch has been recognised for her work in HIV/AIDS and has a Medal of the Order of Australia for her services to medicine in this field. She is now working as Consultant and Mentor in Infectious Diseases and HIV in SE Asia and Oceania. Associate Professor Mijch provides expertise in the field of infectious diseases, particularly in HIV.
• Professor Michael R. Moore is Emeritus Professor in the University of Queensland, Honorary Professor of Griffith University and Adjunct Professor in Queensland University of Technology and in the University of the Sunshine Coast. He is Chair of Water Quality Research Australia and Chair of the Strategic Pesticides Advisory Working Group of the Grains Research & Development Corporation. He sits on the Lead Working Group and the Water Quality Advisory Committee of National Health and Medical Research Council. Professor Moore is Vice-president of the Australasian College of Toxicology and Risk Assessment and is a registered toxicologist in Eurotox & the Institute of Biology, United Kingdom. Professor Moore provides expertise in the field of toxicology.
• Dr Aiden O'Loughlin is a Senior Lecturer in Cardiology at the University of Western Sydney. His major research interest is in coronary artery disease. He trained in cardiology at St Vincent's Hospital in Sydney and at Stanford Hospital in California, USA. Dr O'Loughlin provides expertise in the field of cardiology.
• Dr Stephen Phillips OAM is a General Practitioner with 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. He has 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.
• 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 chairs numerous hospital drug committees and is deputy chair of the Queensland Hospitals Medicines Advisory Committee. Associate Professor Pillans provides expertise in the fields of clinical pharmacology and pharmaceutical chemistry.
• Dr John Riley is the Head of Department of Gastroenterology, Royal North Shore Hospital, Sydney and also holds a teaching position at the University of Sydney. He has a Doctorate of Medicine from the University of Sydney based on research carried out at Columbia Medical Centre, New York, USA. Dr Riley has been an active member of the Gastroenterology Department at Royal North Shore Hospital for many years. Having a particular interest in small bowel disease, inflammatory bowel disease and endoscopy, Dr Riley provides expertise in the field of gastroenterology and hepatology.
• Dr Helen Ritchie is a Senior Lecturer in Anatomy at the Sydney Medical School. Her major research interest is in developmental toxicology with a particular interest in drugs with cardiovascular effects. She also has interests in reproductive toxicology and complementary medicines. She is the current President of the Australian Birth Defects Society. Dr Ritchie provides expertise in the field of toxicology.
• Associate Professor Philip Robinson is a specialist paediatric respiratory physician at the Royal Children's Hospital, Victoria and Head of the Hospitals Cystic Fibrosis Service. Associate Professor Robinson provides expertise in the fields of respiratory disease and paediatrics.
• Dr Geoff Schembri is a senior staff specialist at Royal North Shore Hospital and a physician with over 18 years experience in nuclear medicine and various imaging technologies, particularly ultrasound. Dr Schembri provides expertise in the field of nuclear medicine/radiology.
• Dr David Smallwood is a specialist adult respiratory physician at the Royal Melbourne Hospital and has a PhD on airway remodelling in asthma. He has also undertaken extensive research into chronic obstructive pulmonary disease. Dr Smallwood has experience in cardiac respiratory medicine and pulmonary hypertension. Dr Smallwood provides expertise in the field of respiratory disease.
• 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. She 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. Associate Professor Smith provides expertise in the field of general medical practice to the TGA Advisory Committee on the Safety of Medicines and the TGA Advisory Committee on Prescription Medicines (ACPM).
• Dr Kee Meng Tan is a consultant neurologist trained at Royal Brisbane & Women's Hospital and Mayo Clinic (USA), with specific expertise in epilepsy and autoimmune neurological disease. He is currently a member of The Royal Melbourne Hospital's comprehensive epilepsy program and is engaged in research into inflammatory aspects of epilepsy. Dr Tan provides expertise in the field of neurology.
• Professor Duncan Topliss is Director of Endocrinology & 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 Safety of Medicines. Professor Topliss provides expertise in the fields of endocrinology and pharmacokinetics.
• Associate Professor Beverley Vollenhoven is a gynaecologist and holds a teaching position in the Department of Obstetrics and Gynaecology, Monash University and is Director of Gynaecology, Southern Health, Melbourne. She is also a reproductive endocrinologist and infertility specialist and a clinician at Monash IVF. Associate Professor Vollenhoven provides expertise in the field of gynaecology/reproductive medicine.
• Associate Professor John Ziegler AM is Head of the Department of Immunology and Infectious Diseases and of the HIV Service, Sydney Children's Hospital. His current research interests include genetics of primary immune deficiency disorders (PID), long term outcomes for children with PID; and severe food allergy in Australian children. Dr Ziegler is a Fellow of the Royal Australasian College of Physicians and cofounder of the Australasian Society for HIV Medicine. He also serves on NSW Department of Health Anaphylaxis Education Governing Group and chairs the Immunoglobulin User Group for NSW Health. Associate Professor Ziegler provides expertise in the field of immunology.

ACPM meeting dates

ACPM meetings 2013

Meeting no.	Cut-off date for pre-ACPM response from Sponsor	Meeting date	Venue
2013/1 (288)	15 January 2013	1 February 2013	Canberra
2013/2 (289)	12 February 2013	1 March 2013	Canberra
2013/3 (290)	19 March 2013	5 April 2013	Canberra
2013/4 (291)	21 May 2013	7 June 2013	Canberra
2013/5 (292)	16 July 2013	2 August 2013	Canberra
2013/6 (293)	17 September 2013	4 October 2013	Canberra
2013/7 (294)	19 November 2013	6 December 2013	Canberra

ACPM Pharmaceutical Subcommittee (PSC)

The Pharmaceutical Subcommittee makes recommendations to ACPM and the TGA on the pharmaceutical chemistry, quality control, bioavailability and pharmacokinetics of prescription medicines proposed for registration in Australia.

ACPM Pharmaceutical Subcommittee (PSC) members

Chair

Professor Michael Roberts is a specialist in pharmaceutics and pharmacokinetics. NHMRC SPRF; Professor of Therapeutics & Pharmaceutical Science, University of South Australia and Director, Therapeutics Research Centre, University of Queensland. Professor Roberts is a member of several national and international committees. He has published 338 peer-reviewed papers and is a recipient of numerous scholarships and awards. Professor Roberts is an editor, associate editor and member of editorial boards for many journals.

Members

• Clinical Associate Professor Geoffrey Herkes is a specialist in neurology. He is a Clinical Associate Professor at the University of Sydney and Head of the Department of Neurology, Royal North Shore Hospital, and has a teaching position at the University of Sydney. He has a major research interest in neuropharmacology and epilepsy as well as in general neurology. He attained his PhD at the University of Queensland and studied at the Mayo Clinic, USA. He has held executive positions on many research and clinical associations and bodies within Australia. Dr Herkes has been a member of ADEC and now ACPM since 1999 and was appointed Chair in 2008.
• Associate Professor Juleen Cavanaugh is a specialist in molecular biology. Medical Genetics Research Unit, ANU Medical School & Research School of Biology, Australian National University. She is the Director of Management and Scientific Advisory Committees, Genetic Repositories Australia and member of the American Society of Human genetics.
• Associate Professor Mary Collins is a specialist in medicinal chemistry and molecular pharmacology. Lecturer at the Faculty of Pharmacy, University of Sydney. Recipient of numerous scholarships and awards and a member of the Royal Australian Chemical Institute (RACI), Society for Neuroscience (SfN), Australian Neuroscience Society (ANS) and The Australasian Society of Clinical and Experimental Pharmacologists and Toxicologists (ASCEPT).
• Dr David Foster is a specialist in pharmacometrics and biopharmaceutics. He is a lecturer in pharmacokinetics/pharmaceutics at the School of Pharmacy and Medical Sciences, University of South Australia. Dr Foster is a member of the Drug and Therapeutics Committee (Clinical Trial Group) of the SA Children, Youth and Women's Health Service.
• Professor Carl Kirkpatrick is a specialist in pharmacometrics and biopharmaceutics. Professor of Pharmacy Practice and Head, Department of Pharmacy Practice, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Victoria. Professor Kirkpatrick is Chair, Scientific Advisory Committee, Australasian Society of Clinical and Experimental Pharmacology and Toxicology, member of the Organising Committee for the Population Approach Group in Australia and New Zealand (PAGANZ) and co-administrator, Quality Use of Medicines Mapping project.
• Mr Peter Lublin is a specialist in pharmaceutical manufacturing. He was engaged in all aspects of pharmaceutical manufacturing, quality control, quality assurance, planning and administration for more than 30 years as an employee of a major pharmaceutical manufacturer and in an active consultancy role. In that time he sat on committees involved in the evolution of many standards and NBSL (later TGA) orders and guidelines including the Code of GMP.
• Professor Ross McKinnon is a specialist in pharmaceutical biotechnology and molecular oncology. Associate Head and Professor of Pharmaceutical Biotechnology, School of Pharmacy and Medical Sciences, University of South Australia. Co-founder of PharmaQest. Member, CSIRO Health Sector and P-Health Flagship Advisory Boards, NHMRC Academy (2010, 2011), immediate past-president Australasian Pharmaceutical Sciences Association, Director of the Australian Institute of Policy and Science (AIPS). He has served on NHMRC GRPs and was the National Facilitator for the Translating Health Discovery Super Science project by the Federal Department of Industry, Innovation, Science and Research.
• Professor Andrew McLachlan is a specialist in clinical and experimental pharmacology and Professor of Pharmacy (Aged Care), Faculty of Pharmacy, University of Sydney and Centre for Education & Research on Ageing, Concord RG Hospital, NSW. His main research interests centre on understanding the causes and consequences of variability in response to medicines and how this informs their quality use. He is the inaugural chair of the National Medicines Policy Committee and has served for 10 years on the Australian Sports AntiDoping Authority. In 2006 he was recognised as the Pharmacist of the Year by the Pharmaceutical Society of Australia for his professional contribution.
• Professor Iqbal Ramzan is a recognised expert in drug pharmacokinetics/pharmacodynamics, has published 119 refereed papers and provides high level advice to the Federal Government on drug registration. Professor Ramzan is an international leader in Pharmacy education and is on the executive of the Council of Pharmacy Schools - Australia and New Zealand. Professor Ramzan holds a Diploma from the Australian Institute of Company Directors.
• Emeritus Professor Lloyd Sansom AO is a specialist in pharmaceutics and biopharmaceutics. School of Pharmacy and Medical Sciences, University of South Australia. Chair, Examining Committee, Australian Pharmacy Council; Professor Sansom was a member of the National Medicines Policy Executive; Chair of the Pharmaceutical Benefits Advisory Committee (2001 – 2011); Editor of the Australian Pharmaceutical Formulary and Handbook (APF). He is widely published and is a recipient of numerous scholarships and awards including the inaugural Pharmaceutical Society of Australia Lifetime Achievement Award. Emeritus Professor Sansom is regarded as a leader in his chosen field of pharmacy.
• Dr Desmond B Williams is a specialist in pharmaceutics and biopharmaceutics. Dr Williams is the Program Director, Pharmaceutical Sciences, School of Pharmacy and Medical Sciences, University of South Australia and a member of Royal Australian Chemical Institute, AusBiotech, American Association of Pharmaceutical Scientists and Australasian Pharmaceutical Science Association.
• Associate Professor Erica Wood is a specialist in transfusion medicine, Australian Red Cross Blood Service. Consultant haematologist, Bayside/Southern Health, Melbourne; Honorary consultant haematologist, The Royal Melbourne Hospital and Peter MacCallum Cancer Centre. President, Australian and New Zealand Society of Blood Transfusion. Member of the executive and advisory committees of the Blood Matters/Better Safer Transfusion Program and Chair, Blood Matters Serious Transfusion Incident Reporting haemovigilance program expert group. Associate Chief Examiner in Haematology for the Royal College of Pathologists of Australasia. Member of the World Health Organization's expert advisory panel on transfusion. Member, Board of Directors of the International Society of Blood Transfusion and ISBT working parties on transfusion-transmitted infections, haemovigilance and clinical transfusion practice.

ACPM Pharmaceutical Subcommittee (PSC) meeting dates

PSC meeting dates 2013

Meeting no.	Meeting date
2013/1 (149)	21 January 2013
2013/2 (150)	25 March 2013
2013/3 (151)	27 May 2013
2013/4 (152)	22 July 2013
2013/5 (153)	23 September 2013
2013/6 (154)	25 November 2013

Contacting ACPM

To contact the Advisory Committee on Prescription Medicines

Email	acpm.secretariat@tga.gov.au
Phone	+61 2 6232 8024
Fax	+61 2 6203 1250
Postal address	Therapeutic Goods Administration ACPM Secretariat PO Box 100 Woden ACT 2606 Australia

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