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Session 3 Track 1 - Managing the Practical Impacts of Mergers & Acquisitions: Approaches to Process and Systems Integration in Clinical, Regulatory, and Quality
Session Chair(s)
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)
Streamlining Global TMF Processes Through System Consolidation
Vladimir Pyagay
TransPerfect, United Kingdom
Product Manager
Acquisition Management for Regulatory Operations
Kevin Tompkins, MBA
Bristol Myers Squibb, United States
Executive Director, Regulatory Information & Submission Management
Post-Merger Process Diagnostics: Approach and Methodology Applied to the End-to-End CMC Change
Tilman Burgert, PhD
Accenture, Germany
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