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HL7 Stability Standard Implementation Guide Teleconference Minutes 2011-11-28

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HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes

November 29, 2011

Attendees: Norman Gregory (CVM), Tim Lee (CBER), Tena Wei (CDRH), Catherine Hosage-Norman (Sunovion), Mike Mlodzik (Boehringer Ingelheim Vetmedica, Inc.), Edward Pec (Abbott Laboratories), Art Griesser (Promethues), Sandra Spiewak (Reed Technology and Information Services Inc.), Howard Shatz (Data Conversion Laboratory, Inc.), and April Daly (Lab Objects)

  • The IG passed RICRIM unanimously for publication.
  • Art will talk with Josh about Section 3.21.4 of the HL7 Drug Stability Reporting Validation Procedures document, attached (http://gforge.hl7.org/gf/download/docmanfileversion/6570/8912/HL7DrugStabilityReportingValidationProcedures_Final11-14-11.doc).
  • If you would like to see the minutes form the informational meeting that was held at PhRMA "Health Level 7 Stability Meeting on October 27, 2011" you can do a formal FOI request to FDA or contact PhRMA or your PhRMA representative.
  • The idea of electronic submission is simple, the implementation is hard.
  • Sent Lonnie Smith another e-mail to find out when the FDA web page will be updated.
  • Sent Don Lloyd another e-mail to find out when the the HL7 2011 Normative Edition will be updated with the new eStability information.

genda for December 5, 2011 Teleconference: