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European pharmacovigilance research group

Objective

To undertake the feasibility of establishing a case-cohort surveillance network (Euronet), based on representative regions of the European Union (EU), to monitor the safety of new active substances particularly those marketed under the Centralised & Decentralised Procedures.
To undertake a trans-European case-control study of acute pancreatitis.
To develop and improve methods for pharmacovigilance including spontaneous reporting systems (SRSs), meta-analyses and mechanistic approaches.

The Euronet project will be undertaken in two parts. First, a retrospective model, using data on gastrointestinal haemorrhage and serious blood dyscrasias recently obtained by members of the EPRG as part of a case-control study, will be re-analysed using a case-cohort approach. This will allow risk estimates from the two methods to be compared. Second, a feasibility study will be undertaken in 3 EU regions (Bordeaux, Birmingham and Stockholm) to capture, prospectively, cases of up to 4 conditions associated with serious adverse drug reactions. Simultaneously relevant drug consumption data, for each of the regions, will be acquired particularly for those products granted marketing authorisation under the EC Centralised & Decentralised procedures. Results will be compared with those obtained from SRSs.
The case-control study of drug aetiological factors in acute pancreatitis will involve the identification of 900 cases and l 800 controls across 6 member states (Denmark, Italy, Netherlands, Portugal, Sweden and the United Kingdom. This will permit reliable estimates to be made of the relative risks associated with important therapeutic classes.
Pharmacovigilance methodological research will encompass approaches for improving the promotion, collection and analysis of SRSs; further critical examination of the use of meta-analytical techniques in the overview of observational studies; and the establishment of a tissue bank for the storage of material for patients with serious ADRs.

Funding Scheme

CSC - Cost-sharing contracts

Coordinator

University of Newcastle Upon Tyne
Address
Claremont Place
NE2 4HH Newcastle - Upon Tyne
United Kingdom

Participants (8)

Erasmus Universiteit Rotterdam
Netherlands
Address
50,Dr Molewaterplein
3000 RN Rotterdam
FUNDACIO INSTITUT CATALA DE FARMACOLOGIA
Spain
Address
119-129,Pg Vall D'hebron 119-129
08035 Barcelona
Karolinska Institute
Sweden
Address

14186 Huddinge
Odense Universitet
Denmark
Address
19,Winslowparken
5000 Odense C
Universidade de Coimbra
Portugal
Address

3000 Coimbra
University of Birmingham
United Kingdom
Address
Edgbaston
B15 2TT Birmingham
Università degli Studi di Verona
Italy
Address
Policlinico Borgo Roma
37134 Verona
Université Victor Segalen - BordeauxII
France
Address
146,Rue Léon Saignat
33076 Bordeaux