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HL7 Stability Standard Implementation Guide Teleconference Minutes 2018-10-22

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HL7 Stability Standard Teleconference Minutes

October 22, 2018

Attendees: Norman Gregory (CVM, Tim Lee (CBER), Catherine Hosage-Norman (Module 3 Solutions, LLC), and Art Griesser (Promethues)

  • PQ/CMC is testing the Specification part of the CTD using FHIR, and will move all the PQ/CMC (CTD) information that would benefit from standardization to FHIR. Since the PQ/CMC information moving towards FHIR it makes sense of eStability to do the same.
  • The Validation document has the business rules defined and since we are moving toward FHIR it made no sense to continue working on format and Type and elements names.
  • We will start to learn more about the mechanisms of FHIR.
  • The resources eStability can use from FHIR
  • The maturity levels of the FHIR resources.
  • We will continue to use the audio on the WebEx.
  • There will be no teleconference on 10/29/18.

Agenda for November 5, 2018 Teleconference at 3:05 pm, new WebEx link:

  • Mechanisms of FHIR.
  • We will be using WebEx for sharing documents and for audio. When the WebEx starts click the Audio and have it call you or it will give you a number to call 1-210-795-0506.

Meeting information

Topic: HL7 eStability Date: Every Monday, from Monday, October 8, 2018, to Monday, January 7, 2019 Time: 3:00 pm, Eastern Daylight Time (New York, GMT-04:00)

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