C1C: Submitting Effective GMP Licence Applications
Tracks
Courtyard Room Seminar
| Tuesday, November 19, 2024 |
| 11:30 AM - 12:00 PM |
Details
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.
Speaker: 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.
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.
Speaker: 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.
