GMP forum program

Open the 2023 GMP Forum

Main room 1 - Plenary + Q&A

Speaker: Deputy Secretary – Adjunct Professor John Skerritt

Speaker bio:

Adjunct Professor John Skerritt heads 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; control of drug import, export and production; gene technology and regulation and industrial chemicals regulation.

He was formerly a Deputy Secretary in the Victorian Government and has extensive experience in medical, agricultural and environmental policy, regulation, research management, technology application and commercialisation. John was previously the Deputy Chief Executive Officer of a Commonwealth Statutory Authority, a Ministerial appointee on the Gene Technology Technical Advisory Committee and Chair of the Board of a major international technical organisation. During the 1990s he held senior management positions in The Commonwealth Scientific and Industrial Research Organisation and Cooperative Research Centres.

He has significant experience on Boards of international and national organisations and more than 30 years’ experience in negotiating and leading international technical and commercial collaborations. He is the Chair of the Scientific Advisory Council of the Centre for Innovation in Regulatory Science, Vice-Chair (2016-2022) of the International Coalition of Medicines Regulatory Authorities, Special Advisor to the Board of the Centre for Regulatory Excellence and member of the Advisory Board of the Melbourne Institute for Economic and Social research.

Members of the Manufacturing Quality Branch (MQB) will give a short overview of what we see coming in 2023 and beyond, and then open the floor to any questions from the audience.

Main room 1 - Panel + Q&A

Speaker: Jenny Burnett

Speaker bio:

Jenny Burnett 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 Principles for medicines, blood, cell and tissues products and conducting product recalls for all types of therapeutic goods. MQB also has responsibility for TGO 93 and quality of medicinal cannabis products.

Jenny has a science background, working as a chemist in both private industry and government laboratories. After a number of years in the Laboratories Branch of the TGA, and a stint of living overseas for 3 years, she returned to the TGA and spent time in various pre-market assessment areas in medicine regulation before moving to MQB in mid-2020.

The remote inspection program has allowed TGA, and other regulators, to continue with inspection programs during the COVID pandemic. This session will cover our journey using remote and hybrid inspections and highlight how we can incorporate these new tools into the future.

Main room 1 - Presentation + Q&A

Speaker: Jenny Hantzinikolas

Speaker bio:

Jenny is the Director of GMP inspections section of Manufacturing Quality Branch and has been with the TGA since 2004. She leads a team of 25 GMP inspectors who are located in Melbourne, Sydney, Brisbane and Canberra.

Jenny’s areas of expertise are in sterile and non-sterile medicines including vaccines. Prior to joining in the TGA, she had over 17 years’ experience in pharmaceutical industry sector in sterile and non-sterile medicines as well as vaccines, both bacterial and viral and plasma fractionation processes.

Jenny is also involved in several PIC/S activities as well as ICMRA and ICH groups representing TGA and PIC/S.

Data integrity issues feature as common deficiencies seen by the TGA during GMP inspections. This session will provide an insight into data integrity deficiencies in laboratories, as recorded in TGA inspection reports.

Breakout room 2 - Presentation + Q&A

Speaker: Gaye Camm

Speaker bio:

Gaye Camm is a Senior GMP Inspector in the GMP inspections section of Manufacturing Quality Branch.

Gaye has been with the TGA since 1993, worked in the TGA’s laboratories branch until 2009. Her work in the TGA laboratories exposed Gaye to various computerised systems, both simple and complex, and she has extensive experience in the implementation, use and control of laboratory data acquisition, and laboratory information management systems. In her current role within the inspectorate she serves as a technical expert in the manufacture of complementary medicines, sunscreens, medicinal gases, medicinal cannabis, and chemically synthesised API.

This interactive session will guide manufacturers and sponsors of medicinal cannabis products through their GMP responsibilities under Therapeutic Goods Order TGO 93 - Standard for Medicinal Cannabis and the PIC/S Guide to Good Manufacturing Practice for Medicinal Products.

Various scenarios will be workshopped to enhance your understanding of GMP requirements.

Workshop room 3 - Workshop

Speaker: Paul Crossley & Maurice Makdesi

Speaker bio:

Paul is an Assistant Director in the Manufacturing Quality Branch at the TGA. He joined in 2022 to help manage regulatory reform work within the branch, with a particular focus on Medicinal Cannabis. Prior to his time at the TGA, Paul was a manager of government relations and industry affairs at a large ASX-listed company and a journalist at the ABC. He is also a qualified solicitor, having practised for a number of years in both private practice and in-house at a financial institution.

Maurice Makdessi is a Senior GMP Inspector – Team Leader in the GMP inspections section of Manufacturing Quality Branch. Maurice has been with the TGA since 2009.

Maurice holds scientific/management qualification to masters level. He had over 20 years experience in the pharmaceutical industry sector, holding technical and management positions, both domestically and internationally, in the areas of production, R&D, Quality Control, Quality Assurance, Compliance.

Find out what the inspectors most commonly identify as GMP concerns when undertaking inspections of pharmaceutical manufacturers. You can use this information to help you prepare for your next inspection.

Main room 1 - Presentation + Q&A

Speaker: Emmett Broderick

Speaker bio:

Emmett has been a GMP Inspector within the Manufacturing Quality Branch since 2016. Prior to joining the TGA, Emmett worked in various Quality Assurance and Quality Control roles within pharmaceutical manufacturing and contract laboratory services in Australia and Europe. He is currently involved in the PIC/S Working Group to Propose Revision to the Inspection Report Form.

Australia has a unique framework for regulation of listed and complementary medicines. This session will provide a summary of common GMP deficiencies, and guide companies to better understand our approach.

Breakout room 2 - Presentation + Q&A

Speaker: Paul Stephney

Speaker bio:

Paul Stephney is a Senior Inspector and Technical Specialist for Complementary and Listed Medicines in the GMP inspections section of Manufacturing Quality Branch.

Prior to joining the TGA in 2017, he has spent 25 years working in Quality, Validation and Project Management positions for in the pharmaceutical and medical device industries.

Australian sponsors have an important role in ensuring the quality and safety of medicines supplied in Australia. This session will highlight sponsors’ GMP responsibilities and discuss common deficiencies seen in GMP Clearance applications.

Main room 1 - Presentation + Q&A

Speaker: Stephen Farrell

Speaker bio:

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

Prior to this, Stephen had over 10 years of experience in manufacturing facilities in both Europe and Australia across several categories including medical devices, biological drug substance manufacture, terminally sterilised & aseptic fill/finish operations and radiopharmaceuticals.

Stephen is also the chair of PIC/S Inspection Reliance Working Group tasked with increasing the use of GMP inspection reliance practices across participating authorities.

With the introduction of GMP requirements to Therapeutic Goods Order TGO 93 - Standard for Medicinal Cannabis there is renewed focus on the quality of products being supplied in Australia.

This session will discuss the increasing reports of poor-quality product being received by the TGA, sponsors’ regulatory responsibilities and evidence needed to show GMP for imported products.

Breakout room 2 - Presentation + Q&A

Speakers: Paul Crossley & Maurice Makdessi

Speaker bio:

Paul is an Assistant Director in the Manufacturing Quality Branch at the TGA. He joined in 2022 to help manage regulatory reform work within the branch, with a particular focus on Medicinal Cannabis. Prior to his time at the TGA, Paul was a manager of government relations and industry affairs at a large ASX-listed company and a journalist at the ABC. He is also a qualified solicitor, having practised for a number of years in both private practice and in-house at a financial institution.

Maurice Makdessi is a Senior GMP Inspector – Team Leader in the GMP inspections section of Manufacturing Quality Branch. Maurice has been with the TGA since 2009.

Maurice holds scientific/management qualification to masters level. He had over 20 years experience in the pharmaceutical industry sector, holding technical and management positions, both domestically and internationally, in the areas of production, R&D, Quality Control, Quality Assurance, Compliance.

One of the most common deficiencies observed during GMP inspections is inadequate investigations of process deviations, Out of Specification results or complaints. In this workshop, by working through a scenario with a discussion on the TGA’s expectations, it will help participants perform better detailed investigations.

Workshop room 3 - Workshop

Speaker: Jenny Hantzinikolas

Speaker bio:

Jenny is the Director of GMP inspections section of Manufacturing Quality Branch and has been with the TGA since 2004. She leads a team of 25 GMP inspectors who are located in Melbourne, Sydney, Brisbane and Canberra.

Jenny’s areas of expertise are in sterile and non-sterile medicines including vaccines. Prior to joining in the TGA, she had over 17 years’ experience in pharmaceutical industry sector in sterile and non-sterile medicines as well as vaccines, both bacterial and viral and plasma fractionation processes.

Jenny is also involved in several PIC/S activities as well as ICMRA and ICH groups representing TGA and PIC/S.

The revised Annex 1 to the PIC/S Guide to Good Manufacturing Practice for Medicinal Products, on the manufacture of sterile products, has been published. In Australia we will be undertaking an adoption process before we implement the revised Annex 1 - this session will focus on the key changes and what to expect.

Main room 1 - Presentation + Q&A

Speaker: Matt Davis

Speaker bio:

Matt Davis is a Senior Inspector – 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 sector in quality and technical roles, and has spent time in the UK as a GMDP Inspector for the MHRA.

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.

This session will provide information to help you better prepare to prevent and manage medicine shortages. We will cover TGA’s role in managing shortages, including our regulatory flexibilities to assist with continuity of medicine supply to patients. We will discuss how you can incorporate your own flexibilities to quickly respond when supply issues arise and minimise impact on patients.

Breakout room 2 - Presentation + Q&A

Speaker: Cath Brown

Speaker bio:

Cath Brown is the Director of the Medicine Shortages Section in the Pharmacovigilance Branch. This section receives notifications of medicine shortages and discontinuations from sponsors and works collaboratively to reduce the impact on patients through a range of mitigation, management and communication strategies.

Cath has worked at the TGA for over ten years, including time in the Pharmacovigilance, Scientific Evaluation and Complementary Medicines Branches. She has been fortunate to work on a range of reforms and projects across the TGA including developing new regulatory standards for medicine labelling, serialisation and data matrix codes and tablets and capsules.

The TGA is working through the adoption process for the PIC/S Guide to Good Manufacturing Practice for Medicinal Products, Version 16. This session will outline the adoption process, with a focus on the changes to Annex 13 for Investigational Medicinal Products and Annex 16 for Batch Certification and Authorised Person.

Main room 1 - Presentation + Q&A

Speaker: Lynn Talomsin

Speaker bio:

Lynn Talomsin is currently a Senior GMP Inspector and Technical Specialist for Non-sterile Registered Medicines in the GMP inspections section of Manufacturing Quality Branch.

Lynn worked in a number of companies in the pharmaceutical industry for over 20 years prior to joining the TGA in 2009, holding various positions in R&D, Operations and Quality. During this time, she held managerial and project management lead roles implementing quality and process improvement projects.

Confused about the GMPs for Advanced Therapy Medicinal Products in Australia? This session will explain the similarities and differences between biological and biological medicine regulation.  Annex 2A of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products will be compared to the Australian Code of GMP for Human Blood and Blood Components, Human Tissues and Human Cellular Therapy Products.  The session will also include a holistic overview of contamination control strategy required for Class III/Class IV biologicals.

Breakout room 2 - Presentation + Q&A

Speaker: Alyce Maksoud

Speaker bio:

Alyce Maksoud is a Senior GMP Inspector – Team Leader in the GMP inspections section of Manufacturing Quality Branch. Alyce has been with the TGA since 2005.

Alyce has extensive experience in all aspects of Human Blood and Blood Components and plasma fractionation, Human Tissues, FMT regulation, Haematopoietic Progenitor cells (HPCs) and Cellular and Gene Therapy Product manufacture, including processing, quality management, quality assurance and quality control which includes infectious disease testing for finished products, clinical trials for Biologicals and biological medicine.

Sponsors are responsible for reporting information to the TGA when they become aware of GMP non-compliance at sites used to manufacture their medicines. In this workshop, we will work through an example using a US FDA warning letter as a case study. Participants will gain a better understanding of their responsibilities for reporting GMP non-compliance and the TGA processes after this session.

Workshop room 3 - Workshop

Speaker: Katherine Clark

Speaker bio:

Katherine is the Director of Licensing and Compliance Strategy Section of Manufacturing Quality Branch.

Katherine has a PhD in Cell Biology and worked for over ten years in medical research, most recently in the UK at the University of Cambridge. Katherine joined the TGA in 2002 and worked in biotechnology product evaluation before spending 12 years as a Senior GMP inspector performing inspections of biological and cell therapy manufacturers in Australia and internationally. In her current role, Katherine has responsibility for the licensing and certification of manufacturers and the GMP compliance strategy functions.