HL7 Stability Standard Implementation Guide Teleconference Minutes 2016-09-12
HL7 Stability Standard Teleconference Minutes
September 12 2016
Attendees: Norman Gregory (CVM), Tim Lee (CBER), Mike Mlodzik (Boehringer Ingelheim Vetmedica, Inc.), Michele Cobham (Par/ENDO Pharmaceutical), and James Murphy (Par/ENDO Pharmaceutical)
- 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 9/19/16 or 9/26/16.
Agenda for October 3, 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
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