The PHARMO Institute collaborates with other databases and experts from several EU studies to assess the potential of these collaborations to have PAN-European scientific studies. These collaborations include:
EU-ADR
The EU-ADR project aims to develop an innovative computerized system to detect adverse drug reactions (ADRs), supplementing spontaneous reporting systems. To achieve this objective, EU-ADR will exploit clinical data from electronic healthcare records (EHRs) of over 30 million patients from several European countries (The Netherlands, Denmark, United Kingdom, and Italy).
www.alert-project.org
SOS
The - Safety Of non-Steroidal anti inflamatory drugs - project aims to asses and compare the risk of cardiovascular and gastrointestinal events of Non-steroidal-anti-inflamatory drugs (NSAIDs) with the ultimate goal of providing decision models to clinicians and regulatory authorities, such as medicine agencies.The strategy to be followed consists on first systematically reviewing and analyzing previously published clinical trials and observational studies. Then, the methodological issues and knowledge gaps will be identified. Subsequently, multi-country observational study will be designed and conducted in existing health care databases in the UK, Netherlands, Germany and Italy. The project partners will provide information of more than 35 million individuals from the general population, including an ample representation of children.
www.sos-nsaids-project.org
ARITMO
The ARITMO project claims to analyse the arrhythmic potential of drugs in the following classes of study drugs (> 250 compounds): antipsychotics, anti-infectives (antibacterials, antimycotics and antivirals ) and H1-antihistamines, globally and in specific subgroups (age, co-morbidity, genetically).The strategy to be followed consists on using existing data and generating a wealth of new data through field, database and in silico studies. From the literature and a variety of databases information on the risk of QTc prolongation, Torsade de Pointes, ventricular fibrillation and sudden death will be obtained and analysed at a pre-clinical, clinical and post-marketing level. An international prospective case-control surveillance network will run in UK, Germany, Italy and Netherlands and will collect data on risk factors as well as blood samples for candidate gene analyses.
www.aritmo-project.org
European Network of Centers of Pharmacoepidemiology and Pharmacovigilance
The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP®) is a project led by the European Medicines Agency and developed in collaboration with European experts in the fields of pharmacoepidemiology and pharmacovigilance. Its goal is to further strengthen the post-authorisation monitoring of medicinal products in Europe by facilitating the conduct of multi-centre, independent, post-authorisation studies focusing on safety and on benefit-risk, using available expertise and research experience across Europe. This network of excellence comprises relevant research centres, medical-care centres, healthcare databases, electronic registries and existing European networks covering certain rare diseases, therapeutic fields and adverse drug events of interest.
www.encepp.eu
Partner Organisations
- Erasmus Universitair Medisch Centrum Rotterdam (Netherlands) - Coordinator
- Fundació IMIM, European Projects Management Office (Spain)
- London School of Hygiene and Tropical Medicine (UK)
- Alma Mater Studiorum (Italy)
- Universitaet Bremen (Germany)
- University of Newcastle (UK)
- Fondazione Salvatore Maugeri Clinica del Lavoro e Della Riabilitazione (Italy)
- Charite - Universitaetsmedizin Berlin (Germany)
- Università Degli Studi di Verona (Italy)
- St. George's Hospital Medical School (UK)
- Fondazione Scientifica (Italy)
- Academisch Medisch Centrum bij de Universiteit van Amsterdam (Netherlands)
- Drug Safety Research Trust (UK)
- Universitat Pompeu Fabra, Research Unit on Biomedical Informatics (Spain)
- University of Aveiro – IEETA (Portugal)
- IRCCS Centro Neurolesi “Bonino-Pulejo” (Italy)
- Université Victor-Segalen Bordeaux II, Department of Pharmacology, (France)
- Aarhus University Hospital, Århus Sygehus, Department of Clinical Epidemiology (Denmark)
- AstraZeneca R&D, Safety Informatics and Modelling (Sweden)
- Università di Milano-Bicocca, Unit of Biostatistics and Epidemiology, Department of Statistics (Italy)
- Agenzia Regionale di Sanità, Epidemiology Unit (Italy)
- Pedianet - Societa’ Servizi Telematici SRL (Italy)
- University of Santiago de Compostela, BioFarma Research Group (Spain)
- Tel-Aviv University (Israel)
- Health Search - Italian College of General Practitioners (Italy)
- Imperial College London (UK)
- University of Nottingham (UK)
- Research Triangle Institute (Spain)
- The Research Institute of the McGill University Health Centre (Canada)
- Azienda Ospedaliera di Padova (Italy)
- Azienda Sanitaria Locale della provincia di Cremona (Italy)
