Tuesday 19 November 2024
10:30am - 12:00pm
Eureka Room 1

WS5: How to do an effective recall (Repeat to WS1) [FULL]

Wednesday 20 November 2024
11:00am - 12:30pm
Eureka Room 1

We begin with a tale as old as time – your product, marketed for years without problem, is now a potential risk to consumers. What happens next? When reviewing sponsor’s recall notifications, the TGA isn’t simply looking to tick boxes. In this workshop we will explore real-life case studies and the information we need to assess before agreeing to your recall actions.

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
1:00pm - 3:00pm
Eureka Room 1

WS6: Workshop 2 - Performing Detailed Investigations (Repeat to WS2) [FULL]

Wednesday 20 November 2024
1:30pm - 3:00pm
Eureka Room 1

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, participants will work through a scenario and discuss the TGA’s expectations as well as the principles you need to follow to perform better investigations in your roles.

Jenny Hantzinikolas
Director, Inspections Section

Jenny Hantzinikolas is the Director of the Inspections Section in the Manufacturing Quality Branch in TGA. 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.

Tuesday 19 November 2024
3:30pm - 5:00pm
Eureka Room 1

WS4: How to manage GMP Compliance Signals (Repeat to WS3) [FULL]

Wednesday 20 November 2024
9:00am - 10:30am
Eureka Room 1

TGA licensed manufacturers and Australian sponsors are responsible for reporting information to the TGA when they become aware of GMP non-compliance at sites used to manufacture their medicines.This workshop will explore what a GMP compliance signal is, the responsibilities of manufacturers and sponsors when you become aware of a signal, the type of information you need to provide, and what actions the TGA may take. Participants will work through a case study to gain a better understanding of these responsibilities.

Katherine Clark
Director, GMP Operations and Strategy Section, Manufacturing Quality Branch, TGA. 

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.

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