C4A: GMP Clearance- How we got here and where we are headed
Tracks
Goldfields Theatre Breakout 1
| Tuesday, November 19, 2024 |
| 3:30 PM - 4:00 PM |
Details
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.
Speaker: 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.
Speaker: 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.
