Leveraging Oracle IDMP Enterprise Foundation Suite for Regulatory Compliance
IDMP Update
description
Transcript of IDMP Update
IDMP UpdateIDMP Update
HL7 Activities with other SDOsHL7 Activities with other SDOs
16 May 201016 May 2010
IDMP at HL7 Activities with other SDOs 2
IDMP is five ISO work items 1 of 2
• prEN ISO 11238 Health Informatics – Identification of Medicinal Products – Data elements and structures for the unique identification and exchange of regulated information on Substances
• prEN ISO 11239 Health informatics – Identification of medicinal products – Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging
• prEN ISO 11240 Health informatics – Identification of medicinal products – Data elements and structures for the unique identification and exchange of Units of Measurement
Re-named 13 May 2010
IDMP at HL7 Activities with other SDOs 3
IDMP is five ISO work items 2 of 2
• prEN ISO 11616 Health informatics – Identification of Medicinal Products – Data elements and structures for the unique identification and exchange of regulated pharmaceutical product information
• prEN ISO 11615 Health informatics – Identification of Medicinal Products – Data elements and structures for the unique identification and exchange of regulated
medicinal product information
Re-named 13 May 2010
IDMP at HL7 Activities with other SDOs 4
IDMP: Development Status
• Resolved at ISO TC215 Plenary 13 May 2010:• All 5 work items
– to be forwarded by the ISO/TC215 Secretariat to the ISO Central Secretariat for circulation as a DIS ballot
– via the Vienna Agreement with ISO lead; and – in parallel in all JIC members
• to arrive at the TC secretariat no later than 1 July 2010
IDMP at HL7 Activities with other SDOs 5
IDMP also involves activities in HL7
• The five ISO-led work items
• HL7 Version 3 Standard: Identification of Medicinal Products – Creation and Maintenance Messages (Comment)
• HL7 Version 3 Standard: Orders; Substances CMETs (DSTU)
• HL7 Version 3 Standard: Common Product Model CMETs (DSTU)
IDMP at HL7 Activities with other SDOs 6
TimelinesMay June July August September October November December January February March April
2010 2011
HL7 MeetingsTC215 Meetings
ISO-CEN DIS Ballot
CDISC
HL7
HL7
HL7
HL7 HL7
HL7
HL7Substances
IDMP Messages
Common Product Model
5 ISO-led work items
IDMP Task Force Meeting
IHTSDO, GS1…