Collaborative Regulatory RWE Research

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Sigma Consortium logo




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Through our Barcelona based team, we are a partner center of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) which is led by the European Medicines Agency. We are dedicated to excellence in research by adhering to the ENCePP Guide on Methodological Standards and promoting scientific independence and transparency. We have participated in over 70 studies registered in the HMA-EMA Catalogue of RWD Studies, a publicly accessible resource for the registration of pharmacoepidemiological and regulatory RWE studies. Susana Perez-Gutthann has been elected Co-Chair of the Steering Group and Alejandro Arana is the Co-Chair of the Working Group on Research Standards.

We are also a charter member of the newly-formed SIGMA Consortium, a European federated professional network of excellence created to integrate expertise from multiple ENCePP research centers. This collaboration will facilitate comprehensive real-world research with rigorous methodology to better understand responses to treatments in large populations.

And with our membership in the VAC4EU, the Vaccine Monitoring Collaboration for Europe study network, we are helping to increase the availability of real-world evidence on vaccine coverage, benefits, and risks in Europe to support public health and decision making.

Collaborative Research Partners

    • Saskatchewan Health
    • Aarhus University
    • Southern Denmark University
    • University of Ljubljana
    • Bordeaux University
    • BIPS (GePaRD)
    • Oldenburg University
    • University of Cologne
    • Udine University
    • University of Milano Bicocca (UNIMIB)
    • Tuscany Regional Health Agency (ARS Toscana)
    • PHARMO Institute
    • Utrecht University
    • University Medical Center Utrecht
    • University Medical Center Groningen
    • Aragon Institute of Public Health (IACS)
    • Information System for the Advancement of Research in Primary Care – Jordi Gol Foundation (IDIAP J-G)
    • Foundation for the Promotion of Health and Biomedical Research of the Valencia Region (FISABIO)
    • Spanish Agency of Medicines and Medical Devices (AEMPS)
    • Spanish Center for Pharmacoepidemiological Research (CEIFE)
    • The Spanish Working Group on Chron’s Disease and Ulcerative Colitis (GETECCU), holds ENEIDA patient register
    • Karolinska Institute
    • CPRD
    • Dundee University
    • London School of Health and Tropical Medicine (LSHTM)
    • Carelon Research (formerly HealthCore)
    • Kaiser Permanente Northern California
    • Kaiser Permanente Southern California
    • Kaiser Permanente Washington
    • Optum
    • Regenstrief Institute