HL7 Stability Standard Implementation Guide Teleconference Minutes 2016-05-16
HL7 Stability Standard Teleconference Minutes
May 16, 2016
Attendees: Norman Gregory (CVM), Tim Lee (CBER), Mike Mlodzik (Boehringer Ingelheim Vetmedica, Inc.), Art Griesser (Promethues), Michele Cobham (Par/ENDO Pharmaceutical), James Murphy (Par/ENDO ER Pharmaceutical), and Hardy Oh (Par/ENDO Pharmaceutical)
- 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.
- The re-affirmation ballot of the eStability message passed the ballot at the May HL7 Working Group Meeting.
- There will be no teleconference 5/23/16 or 5/30/16.
Agenda for June 6, 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:
Topic: HL7 eStability Date: Every Monday, from Monday, May 16, 2016, to Monday, September 12, 2016 Time: 3:00 pm, Eastern Daylight Time (New York, GMT-04:00) Meeting Number: 749 100 618 Meeting Password: 1234
To join the online meeting
1. Go to https://fda.webex.com/fda/j.php?MTID=mc46278904b6aec63f49e3fbee5bfa4c7 2. If requested, enter your name and email address. 3. If a password is required, enter the meeting password: 1234 4. Click "Join".
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