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Bethesda North Marriott Hotel and Conference Center

Feb 10, 2020 11:00 AM - Feb 12, 2020 2:15 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Regulatory Submissions, Information, and Document Management Forum

Session 6 Track 3: Inspection Readiness: TMF Data Quality and Completeness Progress

Session Chair(s)

Joanne  Malia, MS, MSc

Joanne Malia, MS, MSc

Director, Development Records Management

Regeneron Pharmaceuticals, United States

This session will discuss the current industry best practices regarding the Trial Master File (TMF), where we are today, and where we will likely go in the future. The first presentation will discuss where we are as an industry with the TMF, describe current challenges, and advances. The second presentation will discuss a sponsor case study, how they overcame challenges, and their resulting best practices. The third presentation will discuss a TMF Reference Model initiative to overcome challenges in exchanging TMF records between sponsors and their partners, CROs, and other collaborators.

Learning Objective :

At the conclusion of this session, participants should be able to:

  • Describe the regulatory expectations when it comes to creation and maintenance of an “audit ready” TMF
  • Determine when to apply risk-based assessment for conducting and documenting quality control activities that will ensure a high-quality eTMF
  • Explain how the eTMF Exchange Mechanism Standard may help sponsors and CROs overcome challenges in exchanging TMF information with other parties


Vera  Buris, MHS

Evolution of TMF: A Case Study to Building a Successful TMF

Vera Buris, MHS

Biogen, United States

Senior Manager, Quality and Operations, Submission Sciences

Ken  Keefer, MBA, PMP

eTMF-EMS: Faster Content Exchange for Inspection Preparation and Submissions

Ken Keefer, MBA, PMP

Keefer Consulting Inc Visa, United States

Principle Consultant

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