RPS Working Group to Discuss Next Major Version Requirements

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The RPS (Regulated Product Submissions) Working Group is preparing for a September 23 working group meeting in Atlanta.

Topics include:

  • Discussion of analysis of ICH requirements list (by the way, were you aware that a list of ICH eCTD Next Major Version (NMV) requirements is available?) and multi-regulatory submissions
  • Complexities around two-way communication for Master Files
  • Labeling confidential information
  • File and folder rules (I thought these were going away!!)
  • Hyperlinking

Just a reminder that all sorts of good stuff is on the HL7 RPS Wiki!

Author: GS

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