15 Case Studies — Replicable Practices: Learn Lessons the Easy Way

Inspections Trends Revealed — Workshop to Compare Inspection Experiences

35+ Speakers —Get Actionable Insights From TMF Leaders and Stakeholders

Hot Topics — Oversight, Automation, Risk-Based Strategies, Artificial Intelligence, and More

10+ Hours of Networking

Diverse Perspectives — Presentations and Panels Featuring CRO and Site Points of View

Integration — Learn Practical Engagement Tips From Multiple Functions

Technology — Interoperability, Bots, Automation, Migration, Dashboards, ePRO, eConsent, and More

The 8th European Trial Master File Summit is designed to put a focus on technology, processes, strategies, multiple points of view, and more which will allow attendees to gain a robust overview of how to manage, process, and enhance their TMF. Technology is now one of the essential means to establish tools that can assist with processes and resources that are necessary to support the use of the system. With the advent of eTMFs, sponsors are now able to achieve so much more beyond completeness for compliance with their TMF. Automation, machine learning and AI allow for the sorting, accessing, processing and analysing of more data, in less time — improving management oversight and efficacy of your Quality Management System. This year’s event will feature quantity needed over three days, exploring how to:

  • Optimise eTMF workflow through interoperable technologies with the way documents are created, collected, managed, and reported on
  • Use disruptive technologies to improve efficiency, Quality, and metrics reporting
  • Garner new perspectives and insights from sites and CROs to improve Quality and compliance
  • Institute Quality Controls to meet oversight and monitoring requirements of ICH E6(R2) using a risk-based approach
  • Implement, migrate, acquire, and remediate eTMF systems in concert with other functional areas

We have expanded this year’s programme to include two tracks on each day, so participants may better tailor their own learning and networking experiences.

On behalf of the Advisory Board and all of us at ExL, we look forward to welcoming you and your peers to London this fall!


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