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Webinar: TMF Inspection Readiness (IR): Avoiding IRregularities IRrespective of International Regulatory Agency

Recorded Wednesday, November 28, 2018 10:00am – 11:00am EST


Trial Master Files (TMFs) have always played a critical role in facilitating audits and inspections of clinical trials; however, TMFs are now seen as indispensable tools for the conduct and oversight of the trial itself. Attend this webinar to learn about the various regulatory expectations of TMFs, and how Complete, Correct, and Current Trial Master Files are reflective of effective clinical trial management.


Key Learning Objectives:

  • Moving TMF Inspection Readiness to a State of Being, not a one-time event
  • Comparing and Contrasting the approach and expectations of the FDA and EMA/MHRA
  • Identifying elements of an effective TMF Quality Management System
  • Explaining Hybrid TMFs and the concept of a Primary eTMF
  • Overcoming obstacles to delivering a Complete, Correct, and Current TMF that is Available and Accessible throughout the conduct of the trial



Terry Endress

Senior Consultant, The Avoca Group


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