Medical Product Information (SPLr5)

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Project Scope

The project will extend the SPL model to develop a message that will allow transmission of a regulatory product information submission (labelling, listing, registration, unique device identifier and associated attributes) as specified by the Global Harmonization Task Force (GHTF) ad-hoc working group on (UDI.) submissions. The project will further provide references to other standards and external terminology resources required to populate the data elements defined in the standard. The work is based on existing work efforts: ISO/TC 215/SC WG6 N 547 (Health Informatics: IS#11615 Identification of Medicinal Products – Data Elements and Structure for the exchange of product information for drug dictionaries) and HL7 Structured Product Labeling and GHTF. This project will revise SPLr4 to leverage the data elements defined in the Common Product Model and reduce the SPL standard to the description of Header and Text information.

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Leadership

SPL Chair: Terry Brunone, theresa.m.brunone@gsk.com

Project Facilitator: Myron Finseth, 763-526-3071, myron.finseth@medtronic.com

Domain Expert: Terrie Reed, terrie.reed@fda.hhs.gov

Domain Expert: Anie Mathews, anie.mathews@fda.hhs.gov

Domain Expert: Jackie Elkin, jackie.elkin@medtronic.com

Modeling Facilitator: Gunther Schadow, gunther@pragmaticdata.com

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Project Team Participation

How to get connected

• First meeting is schedule for May 6, 2010
• Meetings occur every other Thursday, 10:30 eastern
• Telecom: 770-657-9270 . Passcode: 745896

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SPLr5 Project Meeting Minutes

Teleconference May 6, 2010

Medical_Product_Information_minutes_08_26_2010.doc

SPLr5 Project Working Documents

• The Health Level Seven (HL7) May 2010 Ballot Overview
• SPL R4 to R5 presentation -- May 6, 2010.

HL7 Ballot Materials - May 2010

• Medical Product Information (includes Drugs, Devices, Biologics, Veterinary Products) (SPLr5) - Go to Regulated Products / Structure Product Labeling (SPL)

• Common Product Model - Go to Regulated Products / Common Product Model

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HL7 Voting Introduction

• HL7 Voting - pdf

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• HL7 Voting Background - Part 1
• HL7 Voting Ballot Desktop - Part 2
• HL7 Voting Understanding the Ballot Materials - Part 3
• HL7 Voting Casting Ballot - Part 4

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Overall Project Timeline (subject to change)

May 2010 – Project standards go to Ballot

• Medical Product Information (SPLr5) DSTU
• Common Product Model R10 DSTU

Oct 2010 – Project standards go to Ballot

• Medical Product Information (SPLr5) DSTU
• Common Product Model R10 DSTU

Jan 2011 – Project standards go to Ballot

• Medical Product Information (SPLr5) DSTU
• Common Product Model R10 DSTU

May 2011 – Project standards go to Ballot

• Medical Product Information (SPLr5) Normative
• Common Product Model R10 Normative