HL7 Stability Standard Implementation Guide Teleconference Minutes 2017-05-22
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:
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
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
IMPORTANT NOTICE: This WebEx service includes a feature that allows audio and any documents and other materials exchanged or viewed during the session to be recorded. By joining this session, you automatically consent to such recordings. If you do not consent to the recording, discuss your concerns with the meeting host prior to the start of the recording or do not join the session. Please note that any such recordings may be subject to discovery in the event of litigation.
Copyright © Health Level Seven International ® ALL RIGHTS RESERVED. The reproduction of this material in any form is strictly forbidden without the written permission of the publisher.