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Bethesda North Marriott Hotel and Conference Center

Feb 08, 2016 12:00 PM - Feb 10, 2016 5:15 PM

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

Regulatory Submissions, Information, and Document Management Forum

Discuss the end-to-end process for document management, publishing, and technical regulatory requirements in regulatory information management.

Session 6 Track 3 - Trial Master File 2.0...What’s Next?

Session Chair(s)

Betsy  Fallen, RN

Betsy Fallen, RN


BAFallen Consulting LLC, United States

The efficiency and importance of the eTMF is being driven by influences such as the implementation of the TMF Reference Model and guidance from regulatory agencies on their expectations for inspections. What is next for the eTMF? Digitizing, storing, and archiving clinical site documents is the next horizon. The intersection of digital documents and technology solutions is expected to enhance compliance, inspection readiness, and patient safety. The anticipated benefits and challenges of the eISF will be presented by three stakeholders as an eConsent form will be tracked from creation through review and upload to an inspectable repository.


Joanne  Malia, MS, MSc

Trial Master File 2.0 – What’s Next? The Sponsor Perspective

Joanne Malia, MS, MSc

Regeneron Pharmaceuticals, United States

Director, Development Records Management

Eric  Delente, MA

View From an eICF

Eric Delente, MA

Self-employed, United States


Adam  Roth

Essential Document Integration: IRB and Site Perspective

Adam Roth

Schulman IRB, United States

Director, Operations

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