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PROTECT
First published
26/06/2013
Last updated
14/01/2025
Network
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Network identification
Network description
Network details
Contact
Institutions that are part of this network
Network identification
PURI
https://redirect.ema.europa.eu/resource/4199
Network ID
4199
Network name and Acronym
PROTECT
Network countries
Belgium
Denmark
France
Germany
Italy
Netherlands
Poland
Spain
Sweden
Switzerland
United Kingdom
Network website
https://www.imi-protect.eu
ENCePP partner
No
Network description
[PROJECT NOW CLOSED] PROTECT was a public-private European project funded by the Innovative Medicines Initiative Joint Undertaking. It comprised a 5 year research programme to address limitations of current methods in the field of pharmacoepidemiology and pharmacovigilance. The European Medicines Agency was the coordinator and Glaxo Smith Kline was the deputy coordinator of this multi-national consortium of 31 partners. The goal was to strengthen the monitoring of the benefit/risk of medicines in Europe. This was achieved by developing a set of innovative tools and methods to improve the early detection of safety signals, enhance direct data collection from consumers and provide for a continuous benefit/risk monitoring of medicines. In addition, a methodological framework of pharmacoepidemiology studies was developed aiming at increasing the usefulness and reliability of these studies for benefit/risk assessment. All methods were tested to demonstrate their usefulness and applicability. This network was an ENCePP partner.
Network details
Network primary therapeutic area:
Other
Network funding:
EU institutional research programme
Contact
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Main
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Institutions that are part of this network
Pharmacoepidemiology and Pharmacoeconomics (PE2), University of Groningen
Real World Studies, LA-SER Research
Cegedim Strategic Data Medical Research UK
Scientific Affairs, Outcome SARL
Mario Negri Institute for Pharmacological Research (IRFMN)
Division of Pharmacoepidemiology & Clinical Pharmacology (PECP), Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University
Uppsala Monitoring Centre
Wolfson Unit, Newcastle University
Department of Clinical Pharmacy and Toxicology, Maastricht University Medical Centre+ (MUMC+)
Pharmacoepidemiology Research Group, Institute of Medical Informatics, Biometry and Epidemiology, Ludwig-Maximilians-Universitaet Muenchen
Real World & Late Phase Research (RWLPR), Quintiles
Pharmacology Unit - Veneto Pharmacovigilance Centre (Pharmacol UNIVR), University Hospital Verona
Studies conducted by the network
Calcium channel blocker treatments and cancer risk. A methodological protocol to compare the results between databases, across designs: Evaluation of the impact of design/database/population differences on the outcome of the studied association
The risk of acute liver injury associated with the use of antibiotics. A methodological comparison across epidemiological data sources
The risk of acute liver injury with the use of antibiotics. A replication study in the Utrecht Patient Oriented Database
Use of antidepressants and risk of hip/femur fracture. A methodological comparison across data sources and epidemiological design
Use of antiepileptics and risk of suicidality. An exploratory study using the UK General Practice Research Database (GPRD) and data from the Danish registries with an evaluation of available data from further European data sources.
Use of benzodiazepines and risk of hip/femur fracture. A methodological comparison across data sources and epidemiological design.
Use of inhaled long acting beta2 adrenoceptor agonists and the risk for Acute Myocardial Infarction (AMI). A methodological comparison across data sources and epidemiological design
WP6 negative control study: The risk of myocardial infarction not associated with the use of antibiotics: A study using a US database
WP6 Replication Study: The risk of acute liver injury associated with the use of antibiotics: Population based case control study
WP6 replication study: The risk of liver injury associated with the use of antibiotics: A study using a US database with linkage with hospital data
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