HL7 Stability Standard Implementation Guide Teleconference Minutes 2010-01-04

HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes

January 4, 2010

Attendees:

Norman Gregory (CVM), Elizabeth Cormier (CVM), David Longstaff (CVM), Tena Wei (CDRH), JoAnn Ziyad (CFSAN), Catherine Hosage-Norman (Sepracor), Mike Mlodzik (Fort Dodge Animal Health), Paul Tenaglia (Apotex), Mike Yang (ScienTek Software), Diane Miller (Alpharma), Jennifer Rice (Alpharma) and Brent Jones (Chester Spring Consulting)

• The eStability message will be a normative ballot at the May HL7 meeting with the following two changes: Add Text ED attribute to AssociatedStudy and expirationTime attribute to Substance.
• Discussed the Common Product Model message going for normative ballot at the January HL7 meeting and the elements that are common to both it and eStability and its effect to the eStability message.
• Please start trying to use the Input Tool and document any issues. It can be found at https://www.estability.org then click on wiki at top of page and it is at the bottom, file name SMIT-0950.zip and the expiration is 3/1/2010. The first time opening will ask for license key that is provided on the wiki. There is also a Word file ”input_tool_observations” that documents other known issues. You need Microsoft.NET framework, version 2 or higher (most current is 3.5) for the Input Tool to work.

Agenda for January 11, 2010 Teleconference:

• We will continue to use Adobe connect (to join the meeting: https://collaboration.fda.gov/hl7/).
• Start working on How To Document (User Guide) for In Put Tool.