Tuesday 19 November 2024
10:30am - 12:00pm
Goldfields Theatre

This presentation explores the adoption of the updated Annex 1 of the PIC/S GMP Guidelines for sterile medicinal products, and provides a roadmap for manufacturers to help ensure compliance. The presentation will describe key changes and outline practical steps companies should take to prepare. Emphasis will be placed on Gap Analysis, Contamination Control Strategies, upgrading facilities, revision of the Pharmaceutical Quality System and fostering a culture of continuous quality improvements to meet the new regulatory guidance.

Matt Davis
Senior GMP Inspector & Team Leader, Inspections Section

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.

Tuesday 19 November 2024
10:30am - 12:00pm
Eureka Room 2&3

Complementary and listed medicines are considered lower risk medicines as they only contain pre-approved low risk ingredients and make low level health claims. However, poor manufacturing practise can result in substandard or contaminated product, which may not support the health claims being made by the product. Thus, compliance with standards of Good Manufacturing Practice is a cornerstone of TGAs risk-based regulation of these medicines.
In GMP 101 we will discuss the principle-based approach taken by the TGA-Industry Working Group on GMP for Complementary and Listed Medicines in formulating guidance documents for manufacture of these medicines. Recently updated sections of the PIC/S Guide will be in focus, such as implementation of Annex 16 for batch release, and control of starting materials, with a broader ranging review of the risk-based application of GMP.

Gaye Camm
Senior GMP Inspector, Inspections Section

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.

Tuesday 19 November 2024
10:30am - 11:00am
Courtyard Room

Submitting effective GMP Clearances applications can be challenging with many variables at play. It can be easy to make mistakes which result in your application being identified as incomplete. Over 10% of submitted applications end up in this situation. This session will explain how to avoid this as well as other common pitfalls with the application process.

Samuel Borg
Assistant Director, GMP Clearance Section

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.

Tuesday 19 November 2024
11:00am - 11:30am
Courtyard Room

TGA staff often identify several deficiencies or areas requiring clarification during the evaluation of GMP Clearances. Sending Requests For Information (RFI) or Proposal to Not-Issue (PNI) can add significant time onto your applications.
In this seminar, learn about common issues encountered in both the Mutual Recognition Agreement (MRA) and Compliance Verification (CV) pathways to reduce the likelihood of receiving an RFI/PNI in your next application.

Peter Kroek
GMP Evaluator, GMP Clearance Section

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.

Tuesday 19 November 2024
11:30am - 12:00pm
Courtyard Room

Do you need to apply for a new TGA manufacturing licence or change your existing licence?
There are evidence requirements and information you’ll be required to submit to the TGA to apply for a manufacturing licence. There are also requirements to vary, transfer, suspend or revoke your licence. 
In this presentation we will explore the common issues we encounter with submitted domestic licence applications, and detail how you can avoid them when submitting your next application.

Scott Pearce
Assistant Director, GMP Operations and Strategy Section, Manufacturing Quality Branch

Mr 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.

Tuesday 19 November 2024
1:00pm - 1:55pm
Goldfields Theatre

Inspections are a crucial tool the TGA use to assess and monitor a manufacturer’s compliance with GMP. The importance of preparing for inspection, behaviours during inspection, and efficient correspondence during the close out of the inspection dictates how effective the overall inspection process will be. 
This session will explore a TGA inspector’s perspective and expectations for inspection preparation, conduct, and post inspection activities that allow the inspection process to proceed smoothly and achieve a positive outcome for the manufacturer.

Maurice Makdessi
Senior GMP Inspector & Team Leader, Inspections Section

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.  

Gaye Camm
Senior GMP Inspector, Inspections Section

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.

Tuesday 19 November 2024
1:00pm - 1:55pm
Eureka Room 2&3

Australian patients are increasingly accessing medicinal cannabis products through special access and authorised prescriber schemes. There are only two medicinal cannabis products on the Australian Register of Therapeutic Goods that have been assessed by the TGA for quality safety and efficacy. Most medicinal cannabis products taken by patients are ‘unapproved goods’ where the healthcare practitioner is responsible for the safety quality and efficacy of the products prescribed. 
This session discusses the TGA’s role in setting quality requirements for medicinal cannabis products and the responsibilities for everyone in the supply chain. Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Order 2017 includes requirements for compliance with GMP as well as testing and quality controls. The presentation will discuss the responsibilities for compliance with TGO 93 for importers, manufacturers, compounding pharmacies and healthcare practitioners. 

Dr Katherine Clark
Director, GMP operations and Strategy Section

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.

Tuesday 19 November 2024
1:00pm - 1:55pm
Courtyard Room

The world is imperfect, including during the manufacture of therapeutic goods. Things do go wrong from time-to-time and when this happens, products may have to be recalled from the Australian market or other actions need to be taken to ensure consumer safety. Would you know what to do if you needed to recall your product? Or have you done recalls in the past and would like a refresher on the processes? In this session, we will provide an overview of Australia’s recall processes. We will also focus on sponsors’ roles and responsibilities which aim to ensure their recall actions are conducted effectively. 

Sharon Bennett
Assistant Director, Recalls Section

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
Recall Coordinator, Recalls Section

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.

Tuesday 19 November 2024
2:05pm - 3:00pm
Goldfields Theatre

As advancements in therapeutic goods technology continue to evolve the healthcare landscape, we need to make sure our regulatory processes remain contemporary and fit for purpose. In response to stakeholder feedback, we have reviewed and are making improvements to the way recalls are managed and communicated in Australia. In this session, you will hear about the next package of exciting reforms about to implemented, including Australia’s new recall terminologies and the outcomes from the review of our legislative recall powers. 

Craig Davies
Director, Recalls Section 

Craig Davies 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.

Tuesday 19 November 2024
2:05pm - 3:00pm
Eureka Room 2&3

Annex 13 of the PIC/S guide to GMP describes requirements specific to the manufacture of Investigational Medicinal Product (IMP). With the update providing significant clarification of the requirements, this session will focus on areas of common deficiencies observed during TGA inspections of IMP manufacturers.  The session will also explain why IMP is potentially a higher risk class of products and why it is important to apply an appropriate level of GMP.

Lynn Talomsin
Senior GMP Inspector, Inspections Section

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.

Tuesday 19 November 2024
2:05pm - 3:00pm
Courtyard Room

Testing for blood, HPC and biologicals is regarded as high risk, particularly if they are for donor screening. This seminar will help delegates to navigate some of the nuances and outline TGA expectations of what constitute a validation vs verification, adequate number of specimens to challenge LoD for qualitative assays and the importance of independent controls to track assay performance. There will also be a mock validation protocol to work through to facilitate discussion on the strengths and gaps of the proposed validation study.

Samuel Ling
GMP Inspector, Inspections Section

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
Senior GMP Inspector & Team Leader, Inspections Section

Alyce Maksoud professional journey began in Haematology and blood bank, microbiology and immunology where Alyce 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.

Tuesday 19 November 2024
3:30pm - 5:00pm
Goldfields Theatre

GMP Clearances form a crucial part of the TGA’s evaluation of products to be registered or listed on the ARTG as well as ongoing surveillance activities of manufacturers and products throughout their lifecycle. Applying for GMP Clearances in the right way can be challenging and the evaluation of these applications can also be extremely complex. 
This session will focus on the entire GMP Clearance framework including why it’s in place, the important role it plays in the broader regulatory framework as well the multiple backlogs we’ve faced during the past decade. The session will also look towards the future with reforms underway to develop a stronger framework designed to meet future challenges.

Stephen Farrell
Director, GMP Clearance section

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.

Tuesday 19 November 2024
3:30pm - 5:00pm
Eureka Room 2&3

Concept to commercialisation of ATMPS transforming innovative therapies into accessible treatments.
To explore the journey of ATMPs from innovative concepts to market-ready therapies.  To highlight the importance of ATMPs in addressing unmet medical needs.  ATMP represent a new frontier in medicine, offering potential cures and significant advancements for patients with severe or chronic conditions. This session will cover the definition and significance of ATMP? Key steps in the commercialisation process; Challenges faced during development; Importance of collaboration and strategic partnerships and a multidisciplinary approach to successful GMP licensing and market entry on the ARTG.

Alyce Maksoud
Senior GMP Inspector & Team Leader, Inspections Section

Alyce Maksoud professional journey began in Haematology and blood bank, microbiology and immunology where Alyce 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.

Tuesday 19 November 2024
3:30pm - 4:00pm
Courtyard Room

On 1 July 2023 we created entries for MDMA and psilocybine under Schedule 8 of the Poisons Standard. This allowed the prescribing of these medicines by specialist psychiatrists who are authorised under the authorised prescriber scheme, in addition to continued patient access through clinical trials. 
Australia is one of the first jurisdictions to allow access to these medicines, as such there are currently no international quality standards, such as pharmacopoeial monographs, for these medicines. We have created two new therapeutic goods orders (TGOs) for these substances that set out the requirements that must be met to ensure medicines are of appropriate quality.
This session will provide an overview of the new TGOs to help manufacturers and sponsors understand the minimum quality requirements that must be met for both the active pharmaceutical ingredients (API) and finished products. This session will also outline the specific licence authorisations and conditions to manufacture these substances.

Nicole Bottle
Assistant Director, GMP operations and Strategy Section

Nicole is an Assistant Director in the GMP Operations and Strategy Section of 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. 

Tuesday 19 November 2024
4:00pm - 4:30pm
Courtyard Room

Terri Dreyer
Assistant Secretary, HPRG Digital Branch

Terri Dreyer leads Health Products Regulation Group’s Digital Branch in the Department of Health and Aged Care. Terri joined the Department in 2021, to lead delivery of the new headtohealth.gov.au gateway and joined the Therapeutic Goods Administration (TGA) digital program in 2023. Prior to joining the Department of Health and Aged Care, Terri has worked in Commonwealth and state government departments in digital, health, economic, immigration and international portfolios.  This includes roles at the Digital Transformation Agency, the Department of the Prime Minister and Cabinet and the Department of Finance. Terri is an advocate for agile and user-centred delivery methods, to deliver great digital products and outcomes. She holds a Master of Public Policy, Bachelor of Commerce, Bachelor of Arts and Post Graduate Diploma in the Arts (Public Policy).

Tuesday 19 November 2024
4:30pm - 5:00pm
Courtyard Room

Manufacture of medicinal cannabis must occur at sites that comply with one of the GMP standards in subsection 13(2) of TGO 93, and the Australian sponsor of the medicinal cannabis product must hold evidence of GMP compliance in accordance with subsection 13(3) of TGO 93.
How do you know if the GMP evidence you have complies with TGO 93 requirements?
This seminar will provide an overview of GMP evidence requirements and includes hands on activities to help participants identify whether GMP evidence complies or does not comply with TGO 93. 

Nicole Bottle
Assistant Director, GMP operations and Strategy Section

Nicole is an Assistant Director in the GMP Operations and Strategy Section of 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. 

Gaye Camm
Senior GMP Inspector, Inspections Section

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.

The topics and session times in the program are tentative and may be subject to change.