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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 6 Track 3 - Successful Transformation from Start to Finish

Session Chair(s)

Laura J. Sherman, MBA

Laura J. Sherman, MBA

Training Partner, Clinical Business Operations

Vertex Pharmaceuticals, Inc., United States

Learning Objective : Explore change management as it relates to the TMF management process Apply rationale for change management to eTMF implementations, new and old

Speaker(s)

Lisa  Mulcahy

An eTMF System Implementation is just one HUGE Change Management Plan

Lisa Mulcahy

Mulcahy Consulting, LLC, United States

Owner, Principal Consultant

Eric  Cardwell, MBA

Leveraging Business Process Modeling for Improved Performance

Eric Cardwell, MBA

AbbVie, United States

Director, Regulatory Information Management

Darryl  Clarke

Change Management – Outsourcing Regulatory Operations and eCTD

Darryl Clarke

Darryl Clarke Enterprises, United States

Senior Director, Head of Global Regulatory Operations

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