Collaborative Regulatory RWE Research

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 75 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 SIGMA Consortium, a European federated professional network of excellence created to integrate expertise from multiple ENCePP research centers. This collaboration facilitates comprehensive real-world research with rigorous methodology to better understand responses to treatments in large populations.

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.

Additionally, we collaborate with the European Pharmacoepidemiology and Pharmacovigilance (EU PE&PV) Research Network in various EMA-funded projects, including the MINERVA collaboration that was pivotal in laying the foundations for the 2024 launch of the HMA-EMA Catalogues of real-world data sources, studies, institutions and networks. This effort was designed to improve the discoverability and replicability of studies using real-world data, facilitate the discoverability and suitability assessment of data sources to generate real-world evidence for regulatory purposes, improve interoperability between studies and data sources, and improve transparency. 

Collaborative Research Partners

• CANADA
  • Saskatchewan Health
• DENMARK
  • Aarhus University
  • Southern Denmark University
• ESTONIA
  • University of Ljubljana
• FINLAND
  • University of Eastern Finland 
• FRANCE
  • Bordeaux University
• GERMANY
  • BIPS (GePaRD)
  • Oldenburg University
  • University of Cologne
• ITALY
  • University of Milano Bicocca (UNIMIB)
  • Tuscany Regional Health Agency (ARS Toscana)
  • INSPIRE
• NORWAY
  • Norwegian Institute of Public Health
• NETHERLANDS
  • PHARMO Institute
  • Utrecht University
  • University Medical Center Utrecht
  • University Medical Center Groningen
• SPAIN
  • 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
• SWEDEN
  • Karolinska Institute
• UNITED KINGDOM
  • CPRD
  • Dundee University
  • London School of Health and Tropical Medicine (LSHTM)
• UNITED STATES
  • Carelon Research (formerly HealthCore)
  • Kaiser Permanente Northern California
  • Kaiser Permanente Southern California
  • Kaiser Permanente Washington
  • Optum
  • Regenstrief Institute