HL7 Stability Standard Implementation Guide Teleconference Minutes 2012-01-23

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HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes

January 23, 2012

Attendees: Norman Gregory (CVM), Tena Wei (CDRH), Amy Malla (CBER), Catherine Hosage-Norman (Sunovion), Mike Mlodzik (Boehringer Ingelheim Vetmedica, Inc.), Art Griesser (Promethues), and Sandra Spiewak (Reed Technology and Information Services Inc.)

  • Schematron is done, there should be a new version soon. The schematron will give an error for the example in the IG because some of the reference values contain capital letters and underscores. The example in the IG passes the schema rules, it is the schematron (FDA business rules) that will give an error, so it is more of an issue with FDA filing
  • When the example in the IG is corrected and any other editorial changes are made, we would submit the IG to John Quinn at HL7 and he would make the determination if the change is small enough to allow for re-issue or substantive enough to require a re-ballot.
  • The FDA web page has changed and how you navigate to the Data Standards Council (DSC) page, the content is the same. To get to the the DSC page from www.fda.gov, on the top left side click the green icon labeled "For Industry", Under the title "For Industry Topics" in the left column the second to last click "Data Standards" and that will take you to the FDA data standards, click on the standard you are interested in. The direct link to the Data Standards page is http://www.fda.gov/ForIndustry/DataStandards/default.htm
  • Catherine gave a talk about eStability at the PDA New England Chapter Meeting, she is checking to see if she can share the presentation. Here is a link to a brief paragraph about the talk, http://www.fiercepharmamanufacturing.com/story/fda-seeks-electronic-reporting-drug-stability-tests/2012-01-12?utm_medium=rss&utm_source=rss
  • Catherine is looking into the use of XSLT forms that wrap around an XForm so you do not need plug-ins and there are no browser or version issues. She is working with the XForm Jason Rock developed to see if she can get them to work.
  • A point that should have been in the 1/19/12 minutes is that funding is needed to completer the revisions to the style sheet.
  • There will be no teleconference on January 30, 2012.

Agenda for February 6, 2012 Teleconference: