HL7 Stability Standard Implementation Guide Teleconference Minutes 2017-04-10

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HL7 Stability Standard Teleconference Minutes

April 10, 2017

Attendees: Norman Gregory (CVM), Tim Lee (CBER), Catherine Hosage-Norman (Module 3 Solutions, LLC),Mike Mlodzik (Boehringer Ingelheim Vetmedica, Inc.), Michele Cobham (Par Pharmaceutical), 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/.
  • It was decided that instead of comparing the Pragmatic eStability Validator rules document to the HL7 Drug Stability Reporting Validation Procedures we created in 2013 we would ask Pragmatic the following:
Are the rules of the validator following the document on your web page “View Rules” or did you use the rules in HL7 Drug Stability Reporting Validation Procedures created in 2013 on the eStability FDA page, http://www.fda.gov/downloads/ForIndustry/DataStandards/StabilityDataStandard/UCM344277.pdf?  If the rules of the validator are following the HL7 Drug Stability Reporting Validation Procedures on the eStability FDA page then replace “View Rules” document on your web page with the HL7 Drug Stability Reporting Validation Procedures on the eStability FDA page.

If the rules are different, then map the HL7 Drug Stability Reporting Validation Procedures on the eStability FDA page to the document on your web page annotating where each section of the HL7 Drug Stability Reporting Validation Procedures on the eStability FDA page is found. Received a response on 3/21/17 in part “The document from 2013 you linked to might be outdated by new schematron rules that had been added later” and “What you are getting at, might be that we should reconcile the schematron with the 2013 document and produce one new up to date version of it.” I responded back on 4/3/17 in part “The document from 2013, HL7 Drug Stability Reporting Validation Procedures is the authoritative document that the schematron was based on” and “If the eStability schematron was changed, were did these new rules come from. Supply a justification for any changes to the schematron (eStability.sch) so the eStability WG can evaluate them.”

  • There will be no teleconference 4/17/17.

Agenda for April 24, 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, January 23, 2017, to Monday, May 1, 2017 Time: 3:00 pm, Eastern Standard Time (New York, GMT-05:00) Meeting Number: 748 902 508 Meeting Password: 1234

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