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

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

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

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

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

EVDAS functionalities Administrative queries Number of ICSRs transmitted Expedited reporting timelines

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

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

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

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

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

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

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

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

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

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”)

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

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

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

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

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

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

Questions?