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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)
eCTD v4.0: The Path to Implementation
Jared Lantzy, PMP
Booz Allen Hamilton, United States
Lead Associate
eCTD 4 is Sneaking Into Your Submissions Processes
Joel Finkle
Retired, United States
Industry Expert
What is the Impact to the Current Regulatory Information System?
Hitoshi Matsui
CAC Corporation, Japan
Advisor