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Boston Convention and Exhibition Center

Jun 23, 2013 8:30 AM - Jun 27, 2013 12:45 PM

415 Summer Street, , Boston, MA 02210 , USA

DIA 2013 49th Annual Meeting: Advancing Therapeutic Innovation and Regulatory Science

Real, Transparent Dialogue from Three Sponsors: Destination eTMF - Are We There Yet?

Session Chair(s)

Nancie E. Celini, DrPH

Nancie E. Celini, DrPH

Chief Health Technology Advisor and Educator

CAB Inc., United States

This unique interview format includes three industry sponsors in various stages of eTMF transition. This forum is designed to help other sponsors, currently in the process of planning their eTMF strategy and programs, share in these real-world experiences. This open discussion will explore the realities encountered by these sponsor organizations and how they mitigated or plan to mitigate the unexpected barriers.

Learning Objective : Identify the difference between eTMF and TMF management; Define a strategic plan for the eTMF transition; Discuss the benefits, risks and realities of eTMF implementation.

Speaker(s)

Betsy  Fallen, RN

Panelist

Betsy Fallen, RN

BAFallen Consulting LLC, United States

Consultant

Graeme  Currie, PhD

Panelist

Graeme Currie, PhD

Regeneron Pharmaceuticals, United States

Head, Clinical Project Management Office

Ivan P. Walrath, MS

Panelist

Ivan P. Walrath, MS

Pfizer Inc, United States

Process Owner, Trial Master File

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