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Release of the EudraVigilance Data Warehouse and Analysis System (EVDAS) to
National Competent Authorities in Member States
Stefano CappePharmacovigilance and Post-AuthorisationSafety and Efficacy of MedicinesEMEA, EU
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Summary
• EVDAS
• Release of EVDAS to NCAs
• Functionalities included
• Training of NCAs
• Next steps
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EVDAS (I)
• The EudraVigilance Data Analysis System is a database for:– Answering pharmacovigilance queries– Collecting and integrating data from a
variety of Source Systems– Containing cleaned and consolidated data– Preserving historical data
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EVDAS (II)
EudraVigilance EudraVigilance Data WarehouseData Warehouse
Data AnalysisData Analysis
Data Collection – Source systemsData Collection – Source systems
Adverse Reactions (ICSRs)
MedDRA and Standard Terminology
Medicinal Products (EVMPD)
User and Organisations
ETLETL
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Release of EVDAS to NCAs
• The system has been released in July 2007 to:– EMEA internal users– National Competent Authorities
(NCAs)
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EVDAS functionalities
• Administrative queries– Number of ICSRs transmitted– Expedited reporting timelines
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EVDAS functionalities
• Pharmacovigilance queries– Drug/Reaction Reports– Static PRR Reports– Dynamic PRR Reports– Reaction Monitoring Reports– Clinical Trials Reports– Patient Age/Sex Reports– MedDRA Dictionary Reports– Product Dictionary Reports
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Number of ICSRs transmitted
Safety report received monthly by EMEA
(PM top – CT bottom)
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Expedited reporting timelines - NCAs
Reference period1 April 2007
- 30 September 2007
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Expedited reporting timelines - MAHs
Reference period1 April 2007
- 30 September 2007
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Drug-reaction report
This report is used to check the frequency of drug/reaction combinations in EVDAS
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Static PRR reports
Signal highlighted for: PRR 95% LB >1 &
COUNT>=3
Signal highlighted for:PRR>2 &
CHI^2>4 &COUNT>=3
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Static PRR report (graph)
Signal highlighted if the box is all included in the area marked in yellow
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Static PRR report (MedDRA)
Calculation of PRR performed jointly at all levels of the MedDRA
hierarchy
Signal highlighted for: PRR 95% LB>1 &
COUNT>=3
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PRR Dynamic
Signal highlighted if the lower line (PRR 95% LB) enters in area marked in
yellow
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Reaction monitoring report
Today
New
Start Monitoring
A reaction is displayed in the report only if a new ICSR is received in the
monitoring period (“New”)
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Clinical Trial Monitoring
Monitoring of clinical trials ongoing by EUDRACT
Number
It is possible to drill to the list of reactions in the trials
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Patient Age/Sex Reports
Number of cases (y – axis) by age (x – axis) grouped
by sex
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MedDRA Dictionary Reports
It works as a MedDRA browser in EVDAS, it also
allows to browse the Standard MedDRA Queries
(SMQs)
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Training of NCAs
• Users need to receive appropriate training before accessing EVDAS
• Training of NCAs is ongoing:– 4 training courses have been organised
(status 1st October 2007)– 55 NCA users have been trained
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Next Training Dates
• Next training dates available for NCAs:– 8 – 10 October– 22 – 24 October
• Training dates for Marketing Authorisation Holders will be planned once the Access Policy in EudraVigilance has been approved and implemented in EVDAS
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Next steps
• Access to MAHs/Healthcare Professionals/General public
• Additional Analyses– Stratification Analysis for PRR– Medicinal product interactions– Integration of Risk Management Plans– Integration of Signal Tracking Tool
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Questions?
