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Session 4 Track 3: The Intersection of Clinical and Regulatory: Document Management Meets Submission Management
Session Chair(s)
Betsy Fallen, RN
Consultant
BAFallen Consulting LLC, United States
Learning Objective : Determine whether to use the EDM Reference Model or CTD as your classification structure Evaluate options for combining the two models Figure out what to do with supporting or follow-up materials if using just the eCTD
Speaker(s)
What To Do with the EDM Reference Model, When You Think in Terms of the CTD?
Lalana Dararutana, MS
NNIT, United States
Principal Consultant / Business Analyst
From Archiving to Compliance Utilizing Business Process to Create Regulatory Assets
Michelle L. Charles, MPH
University of Pennsylvania, Perelman School of Medicine, United States
Director, Regulatory Affairs, Gene Therapy Program
Opportunities for Efficiency Gains in the Post-Submission Application Process: <i>Submission Archiving and Management</i>
Jessica Lefur
OpenText, United States
Systems Engineer
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