HL7 Stability Standard Implementation Guide Teleconference Minutes 2015-12-14

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HL7 Stability Standard Teleconference Minutes

December 14, 2015

Attendees: Norman Gregory (CVM), Tim Lee (CBER), Catherine Hosage-Norman (Module 3 Solutions, LLC), Mike Mlodzik (Boehringer Ingelheim Vetmedica, Inc.), Art Griesser (Promethues), Nitesh Darji (Phibro Animal Health), Michele Cobham (Par/ENDO Pharmaceutical), James Murphy (Par/ENDO Pharmaceutical), and Hardy Oh (Par/ENDO Pharmaceutical)

  • Issue with the example messages opening the stylesheet have been resolved. It was an issue with www.accessdata.fda.gov.
  • 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 info@module3solutions.com. 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 12/21/15 or 12/28/2015.

Agenda for January 4, 2016 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:

Meeting information


Topic: HL7 eStability Date: Every Monday, from Monday, October 19, 2015, to Monday, January 11, 2016 Time: 3:00 pm, Eastern Daylight Time (New York, GMT-04:00) Meeting Number: 747 006 736 Meeting Password: 1234


To join the online meeting


1. Go to https://fda.webex.com/fda/j.php?MTID=mf44ab83d0800eac2dd100d8d4b248506 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=m569a5eadfb1d5bed4d4906cf742543ab


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: https://fda.webex.com/fda/j.php?MTID=mb7b632877832ab080641caa7591dd862

FDARichMedia@fda.hhs.gov

IMPORTANT NOTICE: This WebEx service includes a feature that allows audio and any documents and other materials exchanged or viewed during the session to be recorded. You should inform all meeting attendees prior to recording if you intend to record the meeting. Please note that any such recordings may be subject to discovery in the event of litigation.