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Session Chair(s)
Mark A. Gray
Senior Project Manager, DSB, CBER, FDA, United States
Learning Objective : Presenters will explain the relationship between RPS and eCTD v4.0, their scope, and their development history including implementation plans. Participants will be able to map existing eCTD terms and concepts to their RPS counterparts, recognize additional functionality and benefits, recognize controlled vocabularies and who manages them, and start preparing for the transition to eCTD v4.0.
Speaker(s)
Jared Lantzy, PMP
Executive Director, Global Regulatory Operations, Novavax, Inc., United States
eCTD v4.0: The Path to Implementation
Joel Finkle
Industry Expert, Retired, United States
eCTD 4 is Sneaking Into Your Submissions Processes
Hitoshi Matsui
Advisor, CAC Corporation, Japan
What is the Impact to the Current Regulatory Information System?