Improve Your TMF Quality

Clinical trials have been extremely diverse, particularly when it comes to TMF. Sharing knowledge and use cases on how organizations are continuing to address these changes with updated SOPs, safety-vigilance systems, remote inspections, and more through the digitization of the TMF is more important than ever, particularly with new guidelines because of COVID-19.

The Fierce European TMF Summit will continue to provide strategies, tools, and methodologies to address your TMF challenges, with a heavy focus on how to manage, process, and develop your TMF.  

Featured Sessions:

  • Keynote: Changes to ICH E6 GCP that Directly Effect Clinical Trial Records 
  • A Look Beyond Document Management: How the TMF Adds Value to Functional Areas
  • Discover Recent TMF Reference Model Changes and Updates
  • Explore Strategies for Maintaining a Contemporaneous TMF
  • Improve Operations and Amplify Your Organisation’s TMF Health

Informative & Interactive Workshops

The European TMF Summit Workshop Day on Monday, 14 November 2022 features 4 professional development trainings designed to provide pharmaceutical and biotech professionals responsible for managing TMF and clinical research a deeper, hands-on approach to learning about achieving optimal quality control, ensuring inspection readiness, and streamlining operations and technology.

Top Reasons to Attend

  • Learn strategies for maintaining a compliant TMF according to inspection trends and changing global regulations 
  • Institute QCs and responsive governance in accordance with inspection trends  
  • Comply with oversight and monitoring requirements of ICH E6(R3) using risk-based approaches and methods 
  • Maintain transparency while transitioning into the new EU-CTR process  
  • Ally with other clinical functions to implement, migrate, acquire, and remediate systems with optimal interoperability  


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