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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 4 Track 3 - Progression and Utilization of the DIA EDM Harmonization Effort (Reference Models)

Session Chair(s)

Emily  Onkka

Emily Onkka

Senior Director, Regulatory Affairs

Pfenex, Inc., United States

Learning Objective : Explain current state of the Reference Models. Present the current sub-committees that are working on extensions and refinements to the models. Invite any to participate.

Speaker(s)

Steve  Scribner

What’s Happening with the DIA EDM Harmonization Effort (Reference Models)?

Steve Scribner

The Scribner Group, United States

Managing Consultant

Olivier  Paris

Leveraging the DIA EDM Reference Model to Speed Up the Deployment of a Regulatory EDMS: Experience, Challenges and Best Practices

Olivier Paris

Ennov, France

President and CEO

Stefanie  Wu

Reconciling Clinical Operations and Regulatory Needs When Leveraging Industry Models

Stefanie Wu

Montrium, Canada

Senior Business Analyst

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