HL7 Stability Standard Implementation Guide Teleconference Minutes 2010-06-28

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HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes

June 28, 2010

Attendees:

Norman Gregory (CVM), Elizabeth Cormier (CVM), David Longstaff (CVM), Tim Lee (CBER), Catherine Hosage-Norman (Sepracor), Mike Mlodzik (Fort Dodge Animal Health), Mike Yang (ScienTek Software), Diane Miller (Alpharma), and Kat Ganesan (Par Pharmaceuticals)

  • A paragraph will be added to the introduction of the IG to the effect that it applies to all regulated products except foods with examples (e.g., test kits, drugs, reagents , medicated feeds, ect.).
  • I will try to reach Mead Walker and Woody Beeler to find out about the changes in the schema.
  • Sent example of cycled study to Mike Yang and getting clarification on the Genzyme examples.
  • Attached is the IG with all the format changes accepted. Save file and change extension from .piz to .zip. PLEASE make comments and/or edits using "Track Changes" to discuss at the July 12th teleconference.
  • We will have no teleconference on July 5th.

Agenda for July 12, 2010 Teleconference: