Professor Tony Lawler is the Deputy Secretary of the Health Products Regulation Group, which works to safeguard and enhance the health of all Australians through effective, timely and risk-proportionate regulation of therapeutic goods, and the control of drug imports, exports and production.  

Prior to joining the Department in June 2023, Tony was the Chief Medical Officer and Deputy Secretary- Clinical Quality, Regulation and Accreditation with the Tasmanian Department of Health. This role included providing leadership to health professionals, system-wide clinical governance oversight, and the regulation of private health service establishments.  

Having studied medicine at the University of Tasmania, Tony has worked in the health system as a Specialist Emergency Physician, Specialist Medical Administrator, and senior health public servant for almost 30 years. During the COVID-19 pandemic, Tony was the Tasmanian Health Service Emergency Operations Commander.  Tony has previously held positions as a member of the Board of the Australian Commission on Safety and Quality in Health Care and the Council of the National Health and Medical Research Council, President of the Australasian College for Emergency Medicine, and Deputy Head of the Tasmanian School of Medicine.   

Tony is a Professor in Health Services with the University of Tasmania.  

Hongxia Jin is the Assistant Secretary of the Manufacturing Quality Branch (MQB). MQB assists in the timely supply of therapeutic goods, ensuring they are of appropriate quality for their entire lifecycle. This primarily relies on assessing manufacturers' compliance with Good Manufacturing Practice for medicines, blood, cell and tissue products and conducting product recalls for all types of therapeutic goods. MQB also has responsibility for TGO 93 and quality of medicinal cannabis products.

Hongxia spent the early years of her public service career in TGA, where she performed various roles including medicine premarket evaluation, post market compliance, manufacturing inspection, and medical device conformity assessment. 

Prior to taking up the current position in late September 2024, Hongxia led the Medicare Integrity Taskforce in response to the Independent Review of Medicare Integrity and Compliance (Philip Review).

Stephen is the Director of the GMP Clearance section of the Manufacturing Quality Branch (MQB) and joined the TGA in January 2016.

The GMP Clearance section is responsible for the GMP evaluation of overseas manufacturing sites as part of a marketing authorisation application. With over 90% of medicines supplied to Australia coming from overseas, the section plays a crucial role in MQB’s goal of assisting in the timely supply of therapeutic goods ensuring they are of appropriate quality for their entire lifecycle. The section also has responsibility for the TGA’s inspection reliance framework which involves the ongoing assessment of other regulatory authorities’ GMP programs for equivalence.

Prior to joining the TGA, Stephen had over 10 years of experience in manufacturing facilities in both Europe and Australia across several categories of Therapeutic Goods including medical devices, biological drug substances, terminally sterilised and aseptic fill/finish operations and radiopharmaceuticals.

Stephen is also the chair of Pharmaceutical Inspection Cooperation Scheme (PIC/S) GMP Inspection Reliance Working Group leading efforts on increasing the use of inspection reliance practices across PIC/S participating authorities. 

Craig is the Director of the Recalls Section of the Manufacturing Quality Branch.  Craig joined the Therapeutic Goods Administration (TGA) in 1990. Since the early 2000s, he has managed sections with responsibility for advertising regulation, export medicine applications, the Adverse Drug Reactions System database and a range of international and national secretariat functions including the Global Harmonization Task Force and numerous TGA expert advisory committees. In 2016, Craig was appointed to his current position as Director of the Recalls Section in the Manufacturing Quality Branch. This Section is responsible for coordinating recall actions for therapeutic goods which are undertaken for goods already supplied to the market for which there are deficiencies in relation to their safety, quality, efficacy / performance, or presentation.

Katherine is the Director of the GMP Operations and Strategy Section of the Manufacturing Quality Branch.  Katherine has a PhD in cell biology and worked for over 10 years in medical research before joining the TGA in 2002. Katherine has worked in various roles in the regulation of medicines and biological products including as an evaluator of biotechnology products and as a GMP inspector team leader for biological and cell therapy manufacturers. Katherine also has experience as a Good Clinical Practice (GCP) inspector and led the GCP inspection pilot program in Australia. In her current role as Director of GMP Operations and Strategy she has responsibility for the business operations of MQB including data reporting systems, the Quality Management System and cost recovery arrangements. The section is also responsible for GMP regulatory reforms including the introduction of quality standards for psilocybine and MDMA and the GMP requirements for medicinal cannabis. In addition, she is responsible for MQB’s GMP signal investigation processes and compliance and enforcement activities.

Jenny is the Director of the Inspections Section of the Manufacturing Quality Branch. She has a degree in Biochemistry and Microbiology. She leads a team of Inspectors who inspect medicines and blood and biological products manufacturers within Australia and overseas. She has been with the TGA for 20 years and was in industry for 17 years. Her experience in industry was in mostly bacterial and viral vaccines and also some experience in oral and topical non sterile medicines.

Matt Davis is a Senior Inspector and Team Leader in the GMP inspections section of Manufacturing Quality Branch. Matt has been with TGA since 2009. Before joining the TGA, Matt held positions in the pharmaceutical industry in both quality and technical roles, and has spent time in the UK as a GMDP Inspector for the Medicines HRA. Matt was the Co-Chair for the PIC/S Working Group on Data Management and Integrity, and is the TGA representative for the PIC/S EMA revision of Annex 1.

Gaye is a Senior GMP Inspector within the Manufacturing Quality Branch. They have an Honours Chemistry degree and 30+ years working within TGA as both an analytical chemist and GMP Inspector. Gaye is a technical specialist for GMP related to manufacture of listed and complementary medicines, medicinal cannabis, sunscreens and medical gases, and GMP related to QC testing and management of laboratory electronic data capture systems. Gaye currently co-chairs the TGA-Industry Working Group on GMP for Complementary and Listed Medicines.

Maurice joined the TGA in 2009, he is currently a team leader in the Inspections section. He has science, engineering and management qualifications to masters level and has over 20 years’ experience in the Pharmaceutical industry and held management posts in quality assurance, quality control, production, and R&D at multinational companies in Australia and Overseas. He contributed to research work in teams developing synthetic active pharmaceuticals and finished dose formulations. He also worked earlier on, in forensic toxicology in research, developing analytical methods for quantitation of drug of abuse residue and trace elements in blood and tissue samples.  

Sharon Bennett has worked for the TGA for approx. 16 years. She recently moved to the position of Deputy Australian Recall Coordinator (Assistant Director) in the Recalls Section of the Manufacturing Quality Branch, after gaining extensive regulatory experience in Medical Device post-market areas. Sharon has 20 years’ experience in nursing, incorporating areas such as chemotherapy, rehabilitation, surgical, aged care and dialysis. Sharon has a Bachelor of Nursing and Nephrology Nursing Certificate and a Cert IV in Government Investigations. 

Brigida Botticelli is an Italian pharmacist with 10-year experience in the pharmacy sector, who joined the Recalls section of the MQB in August 2023.Her expertise lies in medication counseling, prescription verification and therapeutic recommendations. In her current role as a Recall Coordinator, Brigida oversees recall and non-recall actions of Therapeutic Goods in Australia prioritising public safety and regulatory compliance as well as ensuring timely and effective recall processes.

Lynn joined the TGA in 2009 and is currently a Senior GMP Inspector and non-sterile registered medicine Technical Specialist within the Manufacturing Quality Branch. Lynn conducts inspections of domestic and overseas manufacturers of API, and non-sterile and sterile finished dosage forms.Lynn worked for a number of companies in the pharmaceutical industry for over 20 years prior to joining the TGA, holding various positions in R&D, Operations and Quality.  During this time, she held managerial positions as well as project management lead roles implementing quality and process improvement projects.

Samuel Ling is an inspector in the blood, cell, tissue and gene therapy team. He has been with the Inspection Section for 3 years. Prior to that he has more than 13 years of experience in the TGA laboratories. His expertise includes international collaborative Proficiency Studies to establish WHO international reference standards and the development of strategies for in-house qualification and testing methods. Samuel has also received training in glycomics at the Institute of Glycomics, Griffith University and has led several projects in collaboration with the CDC and WHO essential regulatory laboratories. Most notably, the development of stable isotope mass spectrometry for quantitation of flu primary liquid standard. 

Alyce Maksoud’s professional journey began in Haematology and blood bank, microbiology and immunology where she developed a strong foundation in the complexities of blood product management.  Alyce then transitioned into molecular, cord blood banking and cellular therapy, honing her skills in cutting-edge techniques at the time that ensured safe and effective use of stem cells in therapeutic applications.  Her work in cell therapy encompassed both production and quality, allowing her to understand the intricate balance between innovation and regulatory standards. As a GMP inspector, Alyce leveraged her extensive knowledge to uphold the highest standards of quality and safety in the industry. Her leadership role involves guiding a talented team in navigating the regulatory landscape while fostering a culture of excellence and continuous improvement.  Alyce is passionate about the intersection of science and patient care, and remains committed to ensuring that the products they oversee are both safe and effective. In her spare time, Alyce enjoys spending time with family, reading, walking, dancing and listening to music which helps her maintain a balanced perspective in her professional life.

Nadia Saleh has been a GMP Inspector with the Blood Cell Tissue and Gene Therapy Team in the Manufacturing Quality Branch since 2019. She has worked in different areas within the regulatory environment of the TGA and developed extensive experience in the regulation of Medical Devices, Biological Medicines, Blood and Blood Components, Biologicals and Haematopoietic Progenitor Cells, including quality management, quality control and quality assurance in testing of finished biological products and medical devices. Nadia had also worked in NATA accredited testing laboratories including a hospital pathology and the TGA laboratories where she developed experience in analytical testing method techniques applicable to cellular and tissue testing, such as cytogenetic testing, and immune-histochemical staining techniques to identify specific subset of cells.

Nicole is an Assistant Director in the GMP Operations and Strategy Section of the Manufacturing Quality Branch. Nicole joined the TGA in October 2023 to manage regulatory reform work within the branch, and has focused on reforms to the regulation of medicinal cannabis, MDMA and psilocybine. Prior to joining the TGA, Nicole was at the Department of Agriculture, Fisheries and Forestry working on a range of projects to implement regulatory controls to manage biosecurity risks. 

Neale has been employed in the pharmaceutical industry for more than 30 years in various biological manufacturing and quality roles as well as leading product/process/facility development project teams. He has also been involved with industry in a consulting capacity as well as regulatory positions.  He holds a science degree in Biotechnology as well as other further business qualifications. He joined the TGA in 2015 as a Senior GMP Inspector in the Manufacturing Quality Branch and is currently a team leader and continues to perform GMP inspections of sterile and non-sterile pharmaceutical manufacturers.

Jeffery Wan is a GMP Inspector with the Manufacturing Quality Branch. Jeff has a wealth of inspection experience both at the TGA and as an auditor in the Asia Pacific Region in industry. Before joining the TGA he has spent 15 years in the pharmaceutical industry in a number of high level quality and production roles in both sterile manufacturing and FMCG (Fast Moving Consumer Goods) in consumer healthcare. He has a particular interest in BFS technology and has extensive expertise in project management systems and strategies.

Amanda Louise BSc, MClinTRes is a GMP Inspector in the Blood, Tissue, Cell, and Gene Therapy team at the TGA, with over 14 years of advanced biological manufacturing expertise. Her experience includes global technical roles overseeing CAR-T cell product production across EU, US, and APAC regions for clinical and commercial supply. At the GMP Forum 2024, Amanda will discuss regulatory and technical challenges in advanced therapies, drawing on her insights from global tech transfers and her role as a TGA Inspector. She is passionate about ensuring Australians have access to innovative medicines and the impact of digitalisation on manufacturing.

Dr. Fran Harding is a Technical Specialist in human blood, tissues, cell and gene therapies. She has over twenty years’ experience in bioprocess development and manufacturing in Australia and the USA. Her work has explored scale up, tech transfer and production of cell therapies and the development of biomaterials to mimic complex biological microenvironments. In her current role, she acts as an advisor on ATMP and as an inspector of blood and biologics manufacturers. 

Samuel is an Assistant Director in the GMP Clearance section of the Manufacturing Quality Branch (MQB) and joined the TGA in July 2019.Prior to joining the TGA, he has experience working in manufacturing facilities in both pharmaceutical aseptic compounding of oncology products and laboratory management in the FMCG industry. Samuel has a Bachelor of Science (Microbiology) and a Graduate Diploma in Environmental Health Practice.

Peter made the move to Canberra and joined the TGA as an evaluator in the GMP Clearance section in mid-2023, following 5 years in production and quality assurance roles at an aseptic compounding facility. Peter's experience also includes radiopharmaceuticals and compounding at sites in Australia and the United Kingdom, and time as a minerals processing engineer at mining operations around the country.

Scott Pearce is an Assistant Director in the GMP Operations and Strategy Section of the Manufacturing Quality Branch (MQB) and is the Quality Manager for the Branch.Scott joined the TGA in 2018 and has undertaken a number of roles including as the Assistant Director of the Licensing Team. He is currently responsible for managing the system administration, quality and data reporting functions for the Branch in addition to his Quality Manager responsibilities. Scott has a Bachelor of Medical Science with honours in Population Health and Epidemiology.