Transcript Document

Release of the EudraVigilance Data Warehouse
and Analysis System (EVDAS) to
National Competent Authorities in Member
States
Stefano Cappe
Pharmacovigilance and Post-Authorisation
Safety and Efficacy of Medicines
EMEA, EU
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Summary
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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)
Data Analysis
Adverse Reactions (ICSRs)
ETL
Medicinal Products (EVMPD)
EudraVigilance
Data Warehouse
User and Organisations
MedDRA and Standard Terminology
Data Collection – Source systems
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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
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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 period
1 April 2007
- 30 September 2007
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Expedited reporting timelines - MAHs
Reference period
1 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
New
A reaction is displayed in
the report only if a new
ICSR is received in the
monitoring period (“New”)
Start
Monitoring
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Today
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?
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