NZ

Dr Chris Litten

• General Manager, GlycoSyn Technologies, Industrial Research Ltd, NZ.
• Visiting lecturer in Drug Design and Development, University of Auckland. Reviewer for European Journal of Pharmaceutical Sciences, and Journal of Combinatory Chemistry.
• Expertise in GMP, manufacture of active pharmaceutical ingredients, drug discovery, medicinal chemistry, and organic chemistry.

Chemistry

AUS

Professor Stella O'Donnell AO (Chair)

• Emeritus Professor and former Professor of Pharmacology, The University of Queensland. Honorary Professor, School of Health Science, and Visiting Scientist, Institute for Glycomics, Griffith University.
• Registered pharmacist (Queensland). Fellow of the Pharmaceutical Society of Australia. Hon Fellow of the British Pharmacological Society.
• Current Chair, Therapeutic Goods Committee. Member, Joint Expert Committee on Trans Tasman Labelling Requirements for Medicines.
• Past-President of Pharmaceutical Society of Australia (Queensland Branch). Accredited consultant pharmacist (AACPA). Pharmaceutical and educational consultant.
• Expertise in pharmaceutical science, pharmacology, therapeutic goods regulation, quality use of medicines in pharmacy practice.

Pharmaceutical sciences

NZ

Professor Ian Tucker (Deputy Chair)

• Dean, School of Pharmacy and Professor (Pharmaceutical Sciences), University of Otago.
• Member of the Standing Committee on Therapeutic Trials (SCOTT). Former member of the Animal Remedies Board. Member of editorial boards and peer reviewer for a number of international journals.
• Contract research and consultancies to human and veterinary pharmaceutical companies.
• Expertise in pharmaceutics, formulation, drug delivery.

Pharmaceutics

NZ

Associate Professor Simon Malpas

• Associate Professor, Dept. of Physiology and Bioengineering Institute, University of Auckland.
• Member of the National Animal Ethics Advisory Committee, and the Medical Committee for the Auckland Medical Research Foundation. Reviewer for six international funding agencies and eight scientific journals. Secretary of the Physiological Society of New Zealand.
• Expertise in research into control of the cardiovascular system, signal processing and analysis, development of wireless physiological sensors.

Biomedical engineering

AUS

Associate Professor Marcus Vowels AM

• Director, Australian Cord Blood Bank.
• Senior Staff Specialist in Haematology /Oncology in the Centre for Children's Cancer at Sydney Children's Hospital, Randwick. Former Head of the Stem Cell Transplant Program at Sydney Children's Hospital Randwick.
• Member, Therapeutic Goods Committee Sub-committee on Blood and Tissues.

Blood, tissues and cellular therapies

AUS

Professor Yvonne Cossart AO

• Professor, Infection and Immunity, Discipline of Medicine, The University of Sydney. Member, NSW Nosocomial Infection Taskforce.
• Member, Pharmaceutical Subcommittee of the Australian Drug Evaluation Committee.

Microbiology / sterility and virology

AUS

Associate Professor Michael Kimber

• Associate Professor, School of Pharmacy and Molecular Science, James Cook University (Director of Pharmacy Development).
• Industrial pharmacist.
• Member, Pharmaceutical Subcommittee of Australian Drug Evaluation Committee.
• Former Member of Therapeutic Goods Committee.
• Fellow, Australian Institute of Management.
• Member, The Pharmaceutical Society of Australia and Member, International Pharmacy Federation.
• Considerable employment history in the pharmaceutical industry.

Good manufacturing practices / quality systems

NZ

Ms Marion G Miller

• Member of NZ Food Safety Authority Consumer Consultation Group.
• Chair of the governing board of South Centre Community House.
• Visiting Justice, Invercargill Prison.
• Member, St John Invercargill Area Committee.
• Consumer representative, Energy Efficiency Trust.
• Past member of Southland District Health Board.
• Active as an advocate for the needs of the mentally ill and the intellectually less able.
• Considerable experience as representative for diverse range of consumers in both rural and urban areas.

Consumer issues

AUS

Mr David Clayton

• Clinical Operations Director, Pacific Asia & Africa, Global Medical Affairs, Abbott Australasia Pty Ltd.
• Member of the Quality Society of Australasia. Senior member of the American Society for Quality Control.
• Member of the Therapeutic Goods Committee.
• Significant experience in the pharmaceutical industry, in managerial positions in quality assurance, technical support and clinical research.

Manufacture of medicines

AUS

Dr Mark Bowden

• Director, Research & Development, Pfizer Consumer Healthcare.
• Over 10 years service, including as Chair, on various subcommittees of the Australian Self-Medication Industry Association.
• Member of the Therapeutic Goods Committee.
• Member, Joint Expert Committee on Trans Tasman Labelling for Medicines.

Manufacture of medicines

AUS

Mr John Bragg

• General Manager - Operations, Baxter Healthcare Australia Pty Ltd.
• Previous positions as Quality Assurance Manager, Director Quality Assurance and Regulatory Affairs, and Director of Manufacturing, Product Development and Regulatory Affairs.
• Extensive experience in the quality assurance, manufacturing and regulatory functions of sterile therapeutic medical devices and fluid products.
• Extensive GMP and therapeutic goods regulatory affairs management experience.

Manufacture of medical devices

NZ

Ms Brigid Glass

• Quality and Regulatory Affairs Manager, Fisher & Paykel Healthcare.
• Responsible for compliance of global operation, including design, manufacturing and distribution, to all applicable medical device and quality management regulations and standards in all jurisdictions where products are sold.
• Member of the Medical Industry Association of New Zealand Regulatory Committee and the Regulatory Affairs Professional Society.
• Considerable experience in quality management systems, including the practical application of ISO13485 and GMP.

Manufacture of medical devices

AUS

Mr David Edmonds

• Manager, QA & Regulatory Affairs, Peptech.
• Over 30 years experience in the therapeutics goods industry, holding various senior positions in laboratory management, manufacturing and quality assurances.
• Past President, Royal Australian Chemical Institute (RACI) and former Chairman of the RACI NSW Branch Pharmaceutical Science Group.

Chemistry / manufacture of active pharmaceutical ingredients

AUS

Mr Robert Herrington

• Director of Regulatory Affairs and Quality Assurance, Agen Biomedical Ltd (Human and Veterinary Diagnostics).
• Over 30 years experience in the pharmaceutical industry, mostly with CSL in senior international regulatory roles. Experience in R&D, manufacturing, quality assurance and regulatory affairs.

Manufacture of biologicals

AUS

Dr Dominic Wall

• Production Manager, Centre for Blood Cell Therapies & Pathology Manager, Division of Haematology and Medical Oncology, Peter MacCallum Cancer Centre.
• Vice President (Australasia) International Society for Cell Therapy
• Member, TGC Sub-committee on Blood and Tissues.

Manufacture of tissues and cellular therapies

NZ

Mr Rob Shaw

• Technical Director, Healtheries of New Zealand Ltd.
• Background in chemistry, and over 25 years experience in the cosmetic, pharmaceutical and natural products industries, undertaking analytical, product development and regulatory functions.

Natural products / complementary medicines chemistry

AUS

Mr Michael Gepp

• Technical & Regulatory Manager, Pathway International.
• Member of the Therapeutic Goods Administration Office of Complementary Medicines / Industry Consultation Group and Australian Guidelines for Complementary Medicines Consultation group.
• Considerable experience in the complementary medicines industry and extensive knowledge of complementary medicines manufacturing particularly in the area of herbal extracts.

Natural products / complementary medicines chemistry

NZ

Associate Professor Chris Frampton

• Senior academic and biostatistician, Department of Medicine, Christchurch School of Medicine & Health Sciences.
• Member NZ Statistical Association and International Biometrics Society.
• Member, Standing Committee on Therapeutic Trials, Health Research Council of NZ.
• Expertise in statistical techniques, clinical trial design, multivariate correspondence, statistical modelling and predicting.

Statistics

NZ

Associate Professor Nick Holford

• Associate Professor Clinical Pharmacology, University of Auckland. Adjunct Professor, Department of Pharmacology, Georgetown University, Washington, DC, USA.
• Fellow Royal Australasian College of Physicians. Member of editorial boards of a number of international journals.
• Expertise in pharmacokinetics, pharmacodynamics and clinical pharmacology.

Pharmacokinetics

AUS

Associate Professor Elizabeth Dax AM

• Director, National Serology Reference Laboratory.
• Associate Member of the Therapeutic Device Evaluation Committee.
• Member of the AHMAC Blood Safety and Quality Working Group and the NCCTG Invitro Diagnostics Working Group.
• Member, Committee for Australasian Society of HIV Medicine, Australian Society for Microbiology, International AIDS Society, Australian Venerology Society and The Endocrine Society of America.

Development and testing of in vitro diagnostic devices

AUS

Professor Martin Tyas

• Professor, School of Dental Science, University of Melbourne. Published over 140 papers on dental materials.
• Council member of the Royal Australasian College of Dental Surgeons. Member of various Australian Dental Association committees.
• Member of the Medical Devices Evaluation Committee of the Therapeutic Goods Administration.
• Vice-chairman of the Science Commission of the FDI World Dental Federation.
• Leader of the Australian delegation to ISO/TC106 since 1990.
• Consultant in Dental Materiel to the Australian Defence Force since 1985.
• Highly respected and eminent professional in the field of dentistry.

Biomaterials

NZ

Dr Iain Anderson

• Senior Lecturer in Engineering, University of Auckland and Principal Investigator (Orthopaedics and Orthotics) with the Bioengineering Institute.
• Formerly Research Engineer, DSIR/Industrial Research Limited. Member of the Orthopaedic Research Society, USA.
• Member of the Australian Society for Biomaterials.
• Expertise in biomaterials and bioengineering, orthopaedics research.

Biomaterials

AUS

Associate Professor Anne Simmons

• Associate Professor, Graduate School of Biomedical Engineering, University of New South Wales (UNSW).
• Accredited NATA Assessor for biological / biomaterial testing. Member of Standards and Conformance Advisory Council, Dept. of Industry, Science and Resources.
• Member of the Australian Society for Biomaterials.
• Expertise in regulatory and quality systems in biomedical technology and biomaterials.

Toxicology of biomaterials