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Omni Shoreham Hotel

22 sep 2014 8:30 a.m. - 24 sep 2014 1:00 p.m.

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

EDM and ERS 2014

Session Chair(s)

Stacy  Tegan

Stacy Tegan

Program Director

Transcelerate Biopharma, Inc., United States

Learning Objective : Participants will explore common challenges that arise when managing Trial Master Files using a diverse set of eTMF systems resulting from the M&A process. Participants will then walk through an example of process and eTMF system consolidation, review some of the planning considerations, data migration processes, challenges and lessons learned.

Speaker(s)

Vladimir  Pyagay

Streamlining Global TMF Processes Through System Consolidation

Vladimir Pyagay

TransPerfect, United Kingdom

Product Manager

Kevin  Tompkins, MBA

Acquisition Management for Regulatory Operations

Kevin Tompkins, MBA

Bristol Myers Squibb, United States

Executive Director, Regulatory Information & Submission Management

Tilman  Burgert, PHD

Post-Merger Process Diagnostics: Approach and Methodology Applied to the End-to-End CMC Change

Tilman Burgert, PHD

Accenture, Germany

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