Agenda – 6th European Trial Master File Summit

The agenda for the 6th European Trial Master File Summit is in development. If you would like to get involved as a speaker, please contact Scott Grossman at sgrossman@exlevents.com.

Topics under consideration for this year’s event include:

  • How to ensure quality from a site level before documents are incorporated¬†into the TMF
  • The impact of rolling out or implementing a new eTMF
  • Ways to guarantee TMF quality
  • Methods for implementing a second-generation TMF
  • The role change management plays in TMF metrics and dashboards
  • CRO oversight, governance issues and challenges
  • Best practices for creating a TMF/eTMF strategy
  • TMF QC/readiness checks
  • How to destroy files through proper channels while complying with regulations
  • Best practices for managing access and record presentation
  • Ways to prepare for physical and remote inspections
  • Retention of the TMF
  • Data integrity when data is maintained in an eTMF
  • How to respond to MHRA findings from the records group perspective