HL7 Stability Standard Implementation Guide Teleconference Minutes 2017-06-05
HL7 Stability Standard Teleconference Minutes
June 5, 2017
Attendees: Norman Gregory (CVM), Catherine Hosage-Norman (Module 3 Solutions, LLC), Mike Mlodzik (Boehringer Ingelheim Vetmedica, Inc.), Art Griesser (Promethues), Pamela Brown (Merial), Tammy Wright (Dechra), Michele Cobham (Par Pharmaceutical), and Gunther Schadow (Pragmatic)
- PQ/CMC information in Module 3 of the CTD is being worked on using the HL7 Version 3 SPL message. The eStability message will not change but would be another XML message within the PQ/CMC messages. The eStability IG will have to change to use some the data elements that are not being used at this time to be consistent with other PQ/CMC information. Also one eStability wrapper will contain many eStability messages instead of one wrapper containing one message.
- The eStabilty validator and maintenance contract is from Promethues now and can be found at https://estability.prometheuscomputing.com/.
- Gunther sent me the eStability validation rules document with edits and comments (http://gforge.hl7.org/gf/project/rcrim/docman/eStability/eStability-validation-document.doc). We might use portions of it when updating the official document.
- Gunther had some observations and suggestions, my comments are in (); 1) eStability and other v3 messages are different on how the model DUNS and FEI (interestingly eStability was done first), 2) eStability could be moves to the Common Product Model (CPM) and two Common Message Types (CMTs) (not sure how this could be done without going to ballot in HL7), and 3) IT would be a benefit if eStability was combined with CPM (Not sure how much time and work this would take and release and stability data are often on separate systems within industry).
Agenda for June 12, 2017 Teleconference at 3:10 pm:
- We will start looking at and updating the official document “http://www.fda.gov/downloads/ForIndustry/DataStandards/StabilityDataStandard/UCM344277.pdf”
- The phone number is 770-657-9270 and the participation code is 7485962 and we will be using WebEx now for sharing documents:
Meeting information
Topic: HL7 eStability Date: Every Monday, from Monday, May 8, 2017, to Monday, September 11, 2017 Time: 3:00 pm, Eastern Daylight Time (New York, GMT-04:00) Meeting Number: 748 203 828 Meeting Password: 1234
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