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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)
Ellen Reilly, MBA
Vice President, DocuSign, United States
Managing Trust, Identity, and Security in Digital Transactions
Elisa Cascade, MBA
Chief Product Officer, Advarra, United States
Facilitating Collaborations Through Technology
Ajitha Gadangi, MS
Associate Director, Merck & Co., Inc., United States
eTMF for Clinical Data Management