primary & secondary use of ehr systems workshop 11 & 12 october 2007 1 focus on safety tim...
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Primary & secondary use of EHR systems workshop 11 & 12 October 2007 1
Focus on safety
Tim BuxtonHead of Sector, Project Management
EMEA
Primary & secondary use of EHR systems workshop 11 & 12 October 2007 2
Introduction
• Basis of the presentation– Contribution to the discussion; not a position
statement– High level, abstracted perspective
• Today– EudraVigilance– E2B– ISO work items: Pharmacovigilance and identification
of medicinal products• Interaction model
– Stakeholders– Issues
Primary & secondary use of EHR systems workshop 11 & 12 October 2007 3
EudraVigilance
E2
B M
ess
ag
e
Gateway
EVMPD
Post
CT
Vet
EudraVigilance
Warehouse
BusinessIntelligence
…………………
Eudra-Vigilance
DAS
ICSR (H)
ICSR (V)
SUSAR
Primary & secondary use of EHR systems workshop 11 & 12 October 2007 4
N 547 Health informatics Identification of medicinal products
Data elements and structures for the exchange of regulated product
information for drug dictionaries
N 547 Health informatics Identification of medicinal products
Data elements and structures for the exchange of regulated product
information for drug dictionaries
N548 Health informatics Identification of medicinal products
Structures and controlled vocabularies for pharmaceutical product identifiers (PhPIDs)
N548 Health informatics Identification of medicinal products
Structures and controlled vocabularies for pharmaceutical product identifiers (PhPIDs)
N549 Health informatics Identification of medicinal products
Structures and controlled vocabulary for ingredients
N549 Health informatics Identification of medicinal products
Structures and controlled vocabulary for ingredients
N551 Health informatics Identification of medicinal products Structures and controlled vocabulary
for units of measurement
N551 Health informatics Identification of medicinal products Structures and controlled vocabulary
for units of measurement
N550 Health informatics Identification of medicinal products
Structures and controlled vocabulary for units of presentation
N550 Health informatics Identification of medicinal products
Structures and controlled vocabulary for units of presentation
N550 Health informatics Identification of medicinal products
Structures and controlled vocabulary for pharmaceutical dose forms
N550 Health informatics Identification of medicinal products
Structures and controlled vocabulary for pharmaceutical dose forms
N550 Health informatics Identification of medicinal products Structures and controlled vocabulary
for routes of administration
N550 Health informatics Identification of medicinal products Structures and controlled vocabulary
for routes of administration
N546 Health informatics Pharmacovigilance
Structures and controlled vocabulary for laboratory test units for the reporting of laboratory results
N546 Health informatics Pharmacovigilance
Structures and controlled vocabulary for laboratory test units for the reporting of laboratory results
N545 Health informatics Pharmacovigilance
Individual case safety report
Primary & secondary use of EHR systems workshop 11 & 12 October 2007 5
An interaction model?
ADR
SUSAR
E2
B M
ess
ag
e
Signal
Action
Stakeholders:Patients
Healthcare professionals
Pharma companies
Regulators
IT vendors
Data vendors
PSUR
Primary & secondary use of EHR systems workshop 11 & 12 October 2007 6
Issues
• Reporting compliance• Quality of data• Consistency of data• Availability of data
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