OpTImize TMF Roadshow - Melbourne

The OpTImize TMF Roadshow 2026 is a series of global, in-person events that bring together leaders in clinical operations and trial master file (TMF) optimization.

Register today to join us in Melbourne, Australia on 19 August! TMF industry experts will present on cutting-edge automation tools that save time and reduce errors and system-agnostic strategies to maintain a high quality TMF and reduce inspection risks.

Attendees will also have the opportunity to receive free, personalized consultations on risk-based TMF oversight across various eClinical platforms.

AGENDA:

• 9:20 - 9:30 | Welcome & Introductory Remarks
• 9:30 - 10:00 | One Story, Two Models: Latest Updates on TMF Standard Model & ISF Reference Model Led by Gillian Gittens
• 10:00 - 10:30 | Hello, Automate: Using AI to Process, Prevent, and Perform Led by Wei Du
• 10:30 - 10:40 | Tea break
• 10:40 - 11:10 | Red Flags to Green Lights: A Risk-Based TMF Playbook Led by Gillian Gittens & Avani Amin
• 11:10 - 11:40 | Inspection Readiness 2027: ICH E6(R3) Expectations & Real-World War Stories Led by Avani Amin
• 11:40 – 11:45 | Closing