HL7 Stability Standard Implementation Guide Teleconference Minutes 2016-08-15

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HL7 Stability Standard Teleconference Minutes

August 15 2016

Attendees: Norman Gregory (CVM), Tim Lee (CBER), and Tammy Wright (Dechra)

  • 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 8/22/16.

Agenda for August 29, 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, 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".

To view in other time zones or languages, please click the link: https://fda.webex.com/fda/j.php?MTID=mc3fbea500b6eb6bfb77e2aa9ca234021


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.