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RPS News
posted by Kathie Clark @ 10:15 AM
Wednesday, September 2, 2009
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!
Other items on the agenda include ensuring that multi-regulatory, and multi-product submissions are covered adequately.
For the folks worried about file/folder structure, I think we just need to do a “there there, it’s OK”, and let them know that nothing in RPS prevents a file/folder structure from being used, it’s really the same as eCTD in that respect as every file has to sit *somewhere*.
I don’t have high hopes about Hyperlinking becoming disassociated from the file structure (to help with the “broken link” problem over life cycles) — any solution requires software. We can provide enough information in the message that a software implementation can do it, but it’s work for the sponsor, and most folks feel it’s too complex.