16th DIA Conference on European Electronic Data Management and eHealth Topics

The only conference focused on Electronic Content Management that brings together both regulatory agencies and industry to discuss how to reduce reliance on paper documents?

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SESSION 6 - TRACK B - OPTIMISING TMF CONTENT

Session Chair(s)

Russell Joyce

Director

Heath Barrowcliff Consulting Ltd, United Kingdom

eTMF implementations have matured significantly over recent years. We have moved away from a situation where these systems are seen as stand-alone repositories for closed trial documents to being a central tool to facilitate trial management and oversight. This has required alignment and integration with other related technologies and embedding of those technologies into core clinical processes.

Speaker(s)

Sustaining TMF Compliance through Integrated Document Management

Lorrie Dixon

F. Hoffmann-La Roche, Switzerland

Trial Master File Manager

Enhancing TMF Operations with Electronic Signatures

Betsy Fallen, RN

BAFallen Consulting LLC, United States

Consultant

Panel Discussion – Continuing the Themes Introduced by the Speakers and Including an Open Q&A Forum

Eldin Rammell

Phlexglobal Ltd, United Kingdom

Head of Quality Assurance

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