HL7 Stability Standard Implementation Guide Teleconference Minutes 2010-06-28
HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes
June 28, 2010
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:
- We will continue to use Adobe connect (to join the meeting: https://collaboration.fda.gov/hl7/).
- Work on IG (look at comments and edits).