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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 : 1. Ability to separate content from context 2. Recognise content related metadata and contest related metadata 3. Know where the metadata comes from 4. Become aware on how contextual metadata can be reflected on content 5. Learn how to ensure compliance between electronic regulatory documents and regulatory data in IDMP/SPL

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