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Session Chair(s)
Michelle L. Charles, MPH
Director, Regulatory Affairs, Gene Therapy Program
University of Pennsylvania, Perelman School of Medicine, United States
Learning Objective : Describe eTMF (electronic Trial Master File) implementation within major Pharma Company Clinical Data Management. Discuss Best Practices, usage of eTMF reference model, tool used and limitations encountered, Global implementation considerations. Highlight Efficiencies gained, business process development considerations. Ultimate vision of the project from business perspective.
Speaker(s)
Managing Trust, Identity, and Security in Digital Transactions
Ellen Reilly, MBA
DocuSign, United States
Vice President
Facilitating Collaborations Through Technology
Elisa Cascade, MBA
Advarra, United States
Chief Product Officer
eTMF for Clinical Data Management
Ajitha Gadangi, MS
Merck & Co., Inc., United States
Associate Director