HL7 Stability Standard Implementation Guide Teleconference Minutes 2017-01-09

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HL7 Stability Standard Teleconference Minutes

January 9, 2017

Attendees: Norman Gregory (CVM), Tim Lee (CBER), Catherine Hosage-Norman (Module 3 Solutions, LLC), Mike Mlodzik (Boehringer Ingelheim Vetmedica, Inc.), Bill Friggle (Sanofi), Michele Cobham (Par Pharmaceutical), James Murphy (Par Pharmaceutical), and Antonio Cecilio (Par Pharmaceutical)

  • 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 suggested by Pragmatic to take the existing HL7 V3 eStability message and make it an HL7 V3 SPL message by taking the existing eStability message using cut/paste and harmonize to Common Product Model (CPM). They indicating that the HL7 ballot turn around should be fast, but I am not sure that would be the case extensive as the eStability message is. This would be a group decision to be made sometime in the future with discussion and not sure if the tags would survive.
  • There will be no teleconference 1/16/17.

Agenda for January 23, 2017 Teleconference:

  • Comparing the Pragmatic eStability Validator rules document to the HL7 Drug Stability Reporting Validation Procedures we created in 2013. To get to the Pragmatic eStability Validator rules document go to https://validator.pragmaticdata.com/eStability-validator/, click on the “View Rules”, then under the title click “[word]”, depending on what browser you are using you will get the following:

Google Chrome: click on the “validation-documment.doc” on the bottom left and it should open the document in Word. Internet Explorer: in the dialogue box click the “Save as” and save the file to where you want it. Mozilla Firefox: in the dialogue box click the radio button by “Open with” selecting “Microsoft Word (default)”, then click “oK”

The HL7 Drug Stability Reporting Validation Procedures can be found at http://www.fda.gov/downloads/ForIndustry/DataStandards/StabilityDataStandard/UCM344277.pdf *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


To join the online meeting


1. Go to https://fda.webex.com/fda/j.php?MTID=m788c36bf004f55c84b4c5c20c5e4b6f6 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=m0f5258f66c110570df4350fb81dc289c


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=md96134b159aff362b1daf3298a862ed3

FDARichMedia@fda.hhs.gov

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