C2B: Medicinal Cannabis Supply Chains - Know Your Obligations
Tracks
Eureka Room 2&3 Breakout 2
| Tuesday, November 19, 2024 |
| 1:00 PM - 1:55 PM |
Details
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.
Speaker: 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.
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.
Speaker: 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.
