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Focus on safety
Tim Buxton
Head of Sector, Project Management
EMEA
Primary & secondary use of EHR systems workshop 11 & 12 October 2007
1
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
2
ICSR (H)
ICSR (V)
SUSAR
E2B Message
EudraVigilance
Gateway
EudraVigilance
EVMPD
Post
EudraVigilance
DAS
CT
Business
Intelligence
…………………
Vet
Warehouse
Primary & secondary use of EHR systems workshop 11 & 12 October 2007
3
N545 Health informatics
Pharmacovigilance
Individual case safety report
N546 Health informatics
Pharmacovigilance
Structures and controlled vocabulary for laboratory
test units for the reporting of laboratory results
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)
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
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 units of presentation
N550 Health informatics
Identification of medicinal products
Structures and controlled vocabulary
for routes of administration
Primary & secondary use of EHR systems workshop 11 & 12 October 2007
4
ADR
SUSAR
Stakeholders:
Patients
Healthcare
professionals
E2B Message
An interaction model?
PSUR
Pharma
companies
Regulators
Primary & secondary use of EHR systems workshop 11 & 12 October 2007
Signal
Action
IT vendors
Data vendors
5
Issues
•
•
•
•
Reporting compliance
Quality of data
Consistency of data
Availability of data
Primary & secondary use of EHR systems workshop 11 & 12 October 2007
6