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Regulatory Submissions, Information, and Document Management Forum
Session 4 Track 2 - eCTD v4/RPS; Moving Towards Implementation
Mark A. Gray
- Senior Project Manager, DSS, 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 : Plan for coming changes in regulatory submission standards Estimate costs of changing to new standards Interpret guidance and standards from US, EU and Health Level Seven (HL7)
eCTD v4.0: The Path to Implementation
Jared Lantzy, PMP
- Lead Associate
- Booz Allen Hamilton, United States
eCTD 4 is Sneaking Into Your Submissions Processes
- Associate Director, Regulatory Information Management
- BeiGene, United States
What is the Impact to the Current Regulatory Information System?
- CAC Corporation, Japan