HL7 Stability Standard Implementation Guide Teleconference Minutes 2016-10-31

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HL7 Stability Standard Teleconference Minutes

31 2016

Attendees: Norman Gregory (CVM), Tim Lee (CBER), Catherine Hosage-Norman (Module 3 Solutions, LLC), Tammy Wright (Dechra), Michele Cobham (Par/ENDO Pharmaceutical), and Pamela Brown (Merial)

  • PQ/CMC information in Module 3 of the CTD is being worked on using the HL7 Version 3 SPL message. The eStability message will not change but would be another XML message within the PQ/CMC messages. The eStability IG will have to change to use some the data elements that are not being used at this time to be consistent with other PQ/CMC information. Also one eStability wrapper will contain many eStability messages instead of one wrapper containing one message.
  • There will be no teleconference 11/7/16.

Agenda for November 14, 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, September 19, 2016, to Monday, January 9, 2017 Time: 3:00 pm, Eastern Daylight Time (New York, GMT-04:00) Meeting Number: 742 684 687 Meeting Password: 1234


To join the online meeting


1. Go to https://fda.webex.com/fda/j.php?MTID=m944db19e43bbc24ec727ef7ed21ec972 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=mce2e5dd376564c880b98ce84c6ea60e5


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 (Cannot add from mobile devices): https://fda.webex.com/fda/j.php?MTID=md96134b159aff362b1daf3298a862ed3

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. By joining this session, you automatically consent to such recordings. If you do not consent to the recording, discuss your concerns with the meeting host prior to the start of the recording or do not join the session. Please note that any such recordings may be subject to discovery in the event of litigation.