TGA presentations - ARCS 2025 Regulatory Summit

This year’s summit, developed in collaboration with the TGA, dived into key issues surrounding prescription medicines, both pre- and post-marketing application processes, and the unique challenges faced by industry/the sector.

• Session 1 - Priority Designation Workshop
• Session 2 - Collaboration and expedited regulatory pathways
• Session 3 - Navigating evaluation issues and common deficiencies
• Session 4 - ICH Q12:Tools and enablers
• Session 5 - Navigating evaluation issues and common deficiencies
• Session 6 - Reforms on the horizon - Prescription medicines registration