HL7 Stability Standard Implementation Guide Teleconference Minutes 2017-05-22

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HL7 Stability Standard Teleconference Minutes

May 22 2017

Attendees: Norman Gregory (CVM), Catherine Hosage-Norman (Module 3 Solutions, LLC), Mike Mlodzik (Boehringer Ingelheim Vetmedica, Inc.), Pamela Brown (Merial), Bob Dainton (Sanofi), 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 from Pragmatic can be found at https://validator.pragmaticdata.com/eStability-validator/.
  • Gunther presented the document from the validator web site “View Rules” (which is Version 2) compared to the official document “http://www.fda.gov/downloads/ForIndustry/DataStandards/StabilityDataStandard/UCM344277.pdf”. It is closer to the official document with content and numbering. He will be coming out with a version 3 of the document that is on the validator web site with some edits (reorganizing and adding the same abbreviations by whole names (e.g. Address (addr)) to closer resemble the official document.
  • Catherine volunteered to do a line by line comparison of the official document to Version 3 of the document that is on the validator web site
  • There will be no teleconference 5/29/17.

Agenda for June 6, 2017 Teleconference at 3:10 pm:

  • 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


To join the online meeting


1. Go to https://fda.webex.com/fda/j.php?MTID=m2f274682a4f682235bad804138bb34ef 2. If requested, enter your name and email address. 3. If a password is required, enter the meeting password: 1234 4. Click "Join".

To view in other time zones or languages, please click the link: https://fda.webex.com/fda/j.php?MTID=m34d865b139cbcd4eb7bd77d8cf1978df


For assistance


1. Go to https://fda.webex.com/fda/mc 2. On the left navigation bar, click "Support".

Add this meeting to your calendar (Cannot add from mobile devices): https://fda.webex.com/fda/j.php?MTID=m977eb12fc276425a5952d6f3601dcbc4

FDARichMedia@fda.hhs.gov

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