1. National Competent Authorities in Member States
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

2. Summary EVDAS Release of EVDAS to NCAs Functionalities included
Training of NCAs
Next steps

3. 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

4. EVDAS (II) ETL Data Analysis EudraVigilance Data Warehouse
Adverse Reactions (ICSRs)
EudraVigilance
Data Warehouse
Medicinal Products (EVMPD)
ETL
User and Organisations
MedDRA and Standard Terminology
Data Collection – Source systems

5. Release of EVDAS to NCAs
The system has been released in July 2007 to:
EMEA internal users
National Competent Authorities (NCAs)

6. EVDAS functionalities
Administrative queries
Number of ICSRs transmitted
Expedited reporting timelines

7. 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

8. Number of ICSRs transmitted
Safety report received monthly by EMEA
(PM top – CT bottom)

9. Expedited reporting timelines - NCAs
Reference period
1 April 2007
- 30 September 2007

10. Expedited reporting timelines - MAHs
Reference period
1 April 2007
- 30 September 2007

11. Drug-reaction report
This report is used to check the frequency of drug/reaction combinations in EVDAS

12. Static PRR reports Signal highlighted for: PRR 95% LB >1 &
COUNT>=3
Signal highlighted for:
PRR>2 &
CHI^2>4 &
COUNT>=3

13. Static PRR report (graph)
Signal highlighted if the box is all included in the area marked in yellow

14. 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

15. PRR Dynamic
Signal highlighted if the lower line (PRR 95% LB) enters in area marked in yellow

16. 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”)

17. Clinical Trial Monitoring
It is possible to drill to the list of reactions in the trials
Monitoring of clinical trials ongoing by EUDRACT Number

18. Patient Age/Sex Reports
Number of cases (y – axis) by age (x – axis) grouped by sex

19. MedDRA Dictionary Reports
It works as a MedDRA browser in EVDAS, it also allows to browse the Standard MedDRA Queries (SMQs)

20. 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

21. 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

22. 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

23. Questions?