FDA eCTD v4.0 Update

April 10, 2018 10:00–11:00 Eastern Time (US & Canada)

Based on the Health Level Seven (HL7) Regulated Product Submission (RPS) exchange message, eCTD v4.0 is more than just a different backbone. eCTD v4.0 includes more submission metadata, new life-cycle functionality, document reuse, and support for the exchange of information between regulatory authorities and sponsors. The presentation will provide information on the benefits of eCTD v4.0 and will address the implementation process/planning to prepare for the transition to eCTD v4.0.

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