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Regulatory Submissions, Information, and Document Management Forum


Session 3 Track 4: The Future of Electronic Submissions

Session Chair(s)

Michelle L. Charles, MPH

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 : Presenter will discuss experience in testing eCTD v4.0 in cooperation with a regulatory authority and a pharmaceutical industry partner. The current state of documentation on implementing eCTD v4.0 will be analyzed for usability and completeness. Participants will be able to plan for eCTD v4.0 testing with regulatory authorities and start preparing their systems to transition to eCTD v4.0.

Speaker(s)

Robert  Connelly, MBA

Next Stop- RPS (eCTD v4.0)

Robert Connelly, MBA

  • Senior Director, Global Regulatory Operations
  • Incyte, United States
Jared  Lantzy, PMP

eCTD v4.0: Field Testing the Implementation Guidelines

Jared Lantzy, PMP

  • Lead Associate
  • Booz Allen Hamilton, United States
Hans  van Bruggen, MSc

See the Unseen: Across and Within Applications

Hans van Bruggen, MSc

  • CEO and Senior RA Consultant
  • Qdossier, Netherlands