VAC4EU
(Vaccine monitoring collaboration for Europe)

International network of multi-stakeholders that promotes real world evidence creation on vaccine coverage, safety, and effectiveness. VAC4EU has 24 members, from 9 European countries, and 17 data access providers covering an overall population of 152 million.

EU-ADR Alliance
(Exploring and Understanding Adverse Drug Reactions)

European collaboration framework that conducts multi-database studies to answer pharmacoepidemiologic and drug safety questions, covering about 20 million active population.

STUDIES

We are actively conducting 11 Pharmacoepidemiology and Real-Word Evidence studies, and have successfully finalised 3.

• 7 vaccine studies
• 4 medicine studies
• 9 requested by Industry
• 2 requested by the Centre for Disease Control (CDC)
• 2 EMA studies finalised

PUBLICATIONS

Our work has resulted in the generation of 11 publications, furthering the understanding of Pharmacoepidemiology and Real-World Evidence

EMA REGULATORY PROCEDURES

1 Qualification of novel methodologies for medicine development

• Letter of support for Minimal Disease Activity Score (MDA) as primary outcome instrument for clinical studies in psoriatic arthritis (PsA).

3 Innovation Task Force briefing meetings

• Regulatory assessment on the potential use of clinical information collected on the human respiratory syncytial virus disease by the RESCEU IMI project
• Regulatory advice on the values of the concept and methodology of an Integrated Research Platform for Major Depressive Disorder developed by the EU-PEARL IMI project
• Preclinical regulatory assessment for novel molecular therapies developed by the Institute for Bioengineering of Catalonia (IBEC)