C6C: Where does GMP for Plants and Herbs Begin?
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Courtyard Room Seminar
| Wednesday, November 20, 2024 |
| 11:00 AM - 11:30 AM |
Details
This seminar is for manufacturers and sponsors of herbal therapeutic goods, including medicinal cannabis and will provide information on where GMP principles apply in the manufacture of herbal ingredients. At the end of this session manufacturers of herbal products including medicinal cannabis, should be clear on what activities require the application of GMP principles, and understand under what circumstances a GMP licence may not be required.
Speaker: Dr Katherine Clark, Director, GMP Operations and Strategy Section, 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.
Speaker: Nicole Bottle, 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.
Speaker: Dr Katherine Clark, Director, GMP Operations and Strategy Section, 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.
Speaker: Nicole Bottle, 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.
