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Session 3 Track 4: The Future of Electronic Submissions
Session Chair(s)
Michelle L. Charles, MPH
Director, Regulatory Affairs, Gene Therapy Program, University of Pennsylvania, Perelman School of Medicine, United States
This session will cover some of the future changes in electronic submissions including RPS, eCTD 4.0 and the future use of metadata associated with electronic regulatory submissions.
Learning Objective : Understand the historical development of eCTD. Understand the impact the eCTD v4.0 will have on your organization, estimated implementation timelines and regional impact. Steps you can take to ensure you company roadmap is in sync to support RPS (eCTD 4.0)
Speaker(s)
Robert Connelly, MBA
Senior Director, Global Regulatory Operations, Incyte, United States
Next Stop- RPS (eCTD v4.0)
Jared Lantzy, PMP
Executive Director, Global Regulatory Operations, Novavax, Inc., United States
eCTD v4.0: Field Testing the Implementation Guidelines
Hans van Bruggen, MSC
Director of Regulatory Affairs, Celegence, United States
See the Unseen: Across and Within Applications
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