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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)
Next Stop- RPS (eCTD v4.0)
Robert Connelly, MBA
Incyte, United States
Senior Director, Global Regulatory Operations
eCTD v4.0: Field Testing the Implementation Guidelines
Jared Lantzy, PMP
Novavax, Inc., United States
Executive Director, Global Regulatory Operations
See the Unseen: Across and Within Applications
Hans van Bruggen, MSC
Celegence, United States
Director of Regulatory Affairs