HL7 Stability Standard Implementation Guide Teleconference Minutes 2016-12-19
HL7 Stability Standard Teleconference Minutes
December 19 2016
Attendees: Norman Gregory (CVM) 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.
- Mike Yang attend the November AAPS meeting in Denver and went to a stability round table that had key industry people in the stability area. When he asked them if they were monitoring eStability, they had no idea what he was talking about. He will share my contact information with them and their contact information with me.
- We will need new example XML files when the data elements are defined and with the wrapper containing many eStability messages.
- There will be no teleconference 12/26/16 or 1/2/17.
Agenda for January 9, 2017 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
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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".
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1. Go to https://fda.webex.com/fda/mc 2. On the left navigation bar, click "Support".
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