C7A: International GMP - Collaboration | Alignment | Harmonisation
Tracks
Goldfields Theatre Breakout 1
| Wednesday, November 20, 2024 |
| 1:30 PM - 2:00 PM |
Details
International collaboration and alignment on GMP is fundamental to what we do. With over 90% of medicines supplied to Australia coming from overseas, we rely on this to inform and expedite our sovereign decisions on manufacturers around the world. Similarly, reliance on our own GMP inspections contribute to global regulatory efficiency.
This session will provide an overview of GMP international collaboration activities currently underway in forums such as PIC/S, ICMRA and Access. The session will also explore common misconceptions around our international agreements and arrangements and how these inform the level of inspection reliance or recognition for GMP Clearance.
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.
This session will provide an overview of GMP international collaboration activities currently underway in forums such as PIC/S, ICMRA and Access. The session will also explore common misconceptions around our international agreements and arrangements and how these inform the level of inspection reliance or recognition for GMP Clearance.
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.
