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Omni Shoreham Hotel

Sep 22, 2014 8:30 AM - Sep 24, 2014 1:00 PM

2500 Calvert Street NW, , Washington, DC 20008 , USA

EDM and ERS 2014

Session 3 Track 3 - e/TMF Reference Models: Interactive Colossus

Session Chair(s)

Fran  Ross

Fran Ross

Practice Director, Trial Master File

Advanced Clinical, United States

Join this interactive session to hear the latest information about activities and plans for the TMF Reference and OASIS eTMF Interoperability models. Experts will deliver hands-on practical advice about TMF Reference Model adaption: adding types, recommended vs core, differentiating metadata in eTMF, etc. Bring your war stories of model implementations, detailed questions such as “what about doc type xxx”, your considerations for TMF alignment, and share best practices for both paper and eTMF maturity and interoperability with your industry colleagues. This interactive discussion will drive future model activities; our success depends on your expert opinion and detailed feedback.

Speaker(s)

Fran  Ross

TMF Reference Model and Oasis eTMF Standards: What’s Going On?

Fran Ross

Advanced Clinical, United States

Practice Director, Trial Master File

Karen  Roy, MPharm

Adapting the TMF Reference Model: Real World Advice

Karen Roy, MPharm

Phlexglobal, United Kingdom

Chief Strategy Officer

Eric  Rubinson

Panelist

Eric Rubinson

CGI, United States

Director, Consulting Services

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