HL7 Stability Standard Implementation Guide Teleconference Minutes 2015-07-13
HL7 Stability Standard Teleconference Minutes
July 13, 2015
Attendees: Norman Gregory (CVM), Tim Lee (CBER), John Bishop (CBER), Catherine Hosage-Norman (Module 3 Solutions, LLC), Mike Mlodzik (Boehringer Ingelheim Vetmedica, Inc.), and Tammy Wright (Dechra)
- The following announcement was posted on the FDA web page, FDA Resources for Data Standard:
On July 9, 2012, the President signed into law the Food and Drug Administration Safety and Innovation Act (FDASIA) (Public Law 112-144). FDASIA enables FDA to require standardized, fully electronic submissions for certain applications in an effort to facilitate FDA’s review. To that end, the Agency is evaluating the use of electronic data exchange standards for receiving stability and other quality (chemistry, manufacturing and controls) data in eCTD submissions. Also, we are investigating the efficiencies of standardizing other pharmaceutical quality data. FDA is assessing the current HL7 eStability standard. The HL7 Version 3 Implementation Guide: Drug Stability Reporting (eStability) R2, Release 3, published in February 2012, provides technical conformance criteria for eStability files based on some of the same business rules and vocabularies used by the drug establishment, registration and listing process at the FDA. The eStability R2 version implements, in electronic form, a model that is currently used for submission of stability data in paper and eCTD format. FDA is also considering the feasibility of HL7’s FHIR technology for possible future use. The Study Data Standards page (http://www.fda.gov/ForIndustry/DataStandards/StudyDataStandards/default.htm) points to the Stability Data Standards page (http://www.fda.gov/ForIndustry/DataStandards/StabilityDataStandard/default.htm) where the announcement is posted.
- Correction to the re-affirmation of the eStability message, it is based on when it was ASNI approved. The eStability message was ANSI approved in June 2011, so the re-affirmation of the eStability message needs to be by June 2016 (all ANSI approved messages must be re-affirmed every five years).
- Working on having a free editor available.
- The editor is available for download at https://module3solutions.com/ If you have downloaded it and got a "Failure sending mail" message. launch the application again. It will bring you back to License key request page. Take a screen shot of the page and email it to firstname.lastname@example.org. You will then be sent a key. Some SMTP servers are blocking the message.
- You can go to www.eStability.com for another source for creating xml eStability reports.
- There will be no teleconference 7/20/15.
Agenda for July 27, 2015 Teleconference:
- Outstanding issues
- The phone number is 770-657-9270 and the participation code is 7485962 and we will be using WebEx now for sharing documents:
Topic: HL7 eStability Date: Every Monday, from Monday, May 11, 2015 to Monday, October 5, 2015 Time: 3:00 pm, Eastern Daylight Time (New York, GMT-04:00) Meeting Number: 744 956 008 Meeting Password: 1234
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