HL7 Stability Standard Implementation Guide Teleconference Minutes 2017-05-08

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HL7 Stability Standard Teleconference Minutes

May 8, 2017

Attendees: Norman Gregory (CVM), Tim Lee (CBER), Mike Mlodzik (Boehringer Ingelheim Vetmedica, Inc.), James Murphy (Par Pharmaceutical), and Pamela Brown (Merial)

  • 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/.
  • Received a response on 4/21/17 that had this information (I edited and added links): “There were indeed too many rules which had been taken from ICSR, and those all had been removed “View Rules”. The new validation document is on the site and is much more in alignment with the official document “http://www.fda.gov/downloads/ForIndustry/DataStandards/StabilityDataStandard/UCM344277.pdf”. It is actually a re-work based on the official validation rules PDF and then adding only rules from the schematron which were not in the PDF. Even from the numbering of the sections this now is completely parallel and comparable to the PDF.” I did a quick comparison and the section numbering and heading are similar if not the same, still need to compare the content.
  • There will be no teleconference 5/15/17.

Agenda for May 22, 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


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