HL7 Stability Standard Implementation Guide Teleconference Minutes 2017-06-12

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HL7 Stability Standard Teleconference Minutes

June 12, 2017

Attendees: Norman Gregory (CVM), Tim Lee (CBER), Catherine Hosage-Norman (Module 3 Solutions, LLC), , Art Griesser (Promethues), Mike Yang (ScienTek Software) , Tammy Wright (Dechra), 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 and maintenance contract is from Promethues now and can be found at https://estability.prometheuscomputing.com/.
  • The original scehmatron file was based the 2013 official document. The Validation rules document (on Pragmatic site) was a completer re-write going from top down touching every attribute and the differences are very lager between the two documents.
  • Do we need both the DUNS# and FEI#? Should we also add the GeoCode?
  • Highlight the section that are the business rules and have a table at the end of the document with listing the business rules.
  • Need to make sure we stay 508 compliant.
  • ReasonCode does need an code system.
  • HL7 seems to be a moving target.
  • There will be no teleconference 6/19/17.

Agenda for June 26, 2017 Teleconference at 3:10 pm:

  • Continue working on updating the validation document.
  • 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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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".

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

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