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

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

View the Webinar recording and slides:

 

Presenter:

Terry Endress

Senior Consultant, The Avoca Group

 

Hosted by:

        

 

Join Avoca for a panel discussion on TMF Inspection With a Quality Management System at ExL’s 8th Trial Master File Summit