RPS Working Group to Discuss Next Major Version Requirements
The RPS (Regulated Product Submissions) Working Group is preparing for a September 23 working group meeting in Atlanta.
- 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!!)
Just a reminder that all sorts of good stuff is on the HL7 RPS Wiki!