Release of the Eudra Vigilance Data Warehouse and
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Release of the Eudra. Vigilance 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 www. diahome. org
Summary • • • EVDAS Release of EVDAS to NCAs Functionalities included Training of NCAs Next steps www. diahome. org
EVDAS (I) • The Eudra. Vigilance 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 www. diahome. org
EVDAS (II) Data Analysis Adverse Reactions (ICSRs) ETL Medicinal Products (EVMPD) Eudra. Vigilance Data Warehouse User and Organisations Med. DRA and Standard Terminology Data Collection – Source systems www. diahome. org
Release of EVDAS to NCAs • The system has been released in July 2007 to: – EMEA internal users – National Competent Authorities (NCAs) www. diahome. org
EVDAS functionalities • Administrative queries – Number of ICSRs transmitted – Expedited reporting timelines www. diahome. org
EVDAS functionalities • Pharmacovigilance queries – – – – Drug/Reaction Reports Static PRR Reports Dynamic PRR Reports Reaction Monitoring Reports Clinical Trials Reports Patient Age/Sex Reports Med. DRA Dictionary Reports Product Dictionary Reports www. diahome. org
Number of ICSRs transmitted Safety report received monthly by EMEA (PM top – CT bottom) www. diahome. org
Expedited reporting timelines - NCAs Reference period 1 April 2007 - 30 September 2007 www. diahome. org
Expedited reporting timelines - MAHs Reference period 1 April 2007 - 30 September 2007 www. diahome. org
Drug-reaction report This report is used to check the frequency of drug/reaction combinations in EVDAS www. diahome. org
Static PRR reports Signal highlighted for: PRR 95% LB >1 & COUNT>=3 Signal highlighted for: PRR>2 & CHI^2>4 & COUNT>=3 www. diahome. org
Static PRR report (graph) Signal highlighted if the box is all included in the area marked in yellow www. diahome. org
Static PRR report (Med. DRA) Calculation of PRR performed jointly at all levels of the Med. DRA hierarchy Signal highlighted for: PRR 95% LB>1 & COUNT>=3 www. diahome. org
PRR Dynamic Signal highlighted if the lower line (PRR 95% LB) enters in area marked in yellow www. diahome. org
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 www. diahome. org Today
Clinical Trial Monitoring of clinical trials ongoing by EUDRACT Number It is possible to drill to the list of reactions in the trials www. diahome. org
Patient Age/Sex Reports Number of cases (y – axis) by age (x – axis) grouped by sex www. diahome. org
Med. DRA Dictionary Reports It works as a Med. DRA browser in EVDAS, it also allows to browse the Standard Med. DRA Queries (SMQs) www. diahome. org
Training of NCAs • Users need to receive appropriate training before accessing EVDAS • Training of NCAs is ongoing: – 4 training courses have been organised (status 1 st October 2007) – 55 NCA users have been trained www. diahome. org
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 Eudra. Vigilance has been approved and implemented in EVDAS www. diahome. org
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 www. diahome. org
Questions? www. diahome. org
