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Session 4 Track 2 - eCTD v4/RPS; Moving Towards Implementation
Session Chair(s)
Mark A. Gray
Senior Project Manager, DSB, CBER
FDA, United States
Now that the Regulated Product Submission (RPS) Release 2 is a normative standard and the International Council for Harmonisation (ICH) is finalizing the eCTD v4 implementation package, the focus is now on preparing for the implementation of eCTD v4. Based on the Health Level Seven (HL7) RPS exchange message, eCTD v4 is more than just a different backbone. eCTD v4 includes more submission metadata, new life cycle functionality, document reuse, and support for the exchange of information between regulatory authorities and sponsors. This session will provide information on the development and benefits of eCTD v4 but will also address the impact of the new standard and provide an update on the implementation process to prepare for the transition to eCTD v4.
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
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