Both WEB-RADR 2 and ConcePTION rely on Lareb's national pharmacovigilance infrastructure and expertise in collecting and analyzing real-world drug safety reports.
STICHTING LAREB
Dutch national pharmacovigilance centre specialising in adverse drug reaction monitoring and medication safety in pregnancy and lactation.
Their core work
Lareb is the Netherlands Pharmacovigilance Centre — the national institution responsible for collecting, analyzing, and communicating reports of adverse drug reactions from healthcare professionals and patients across the Netherlands. Their core work is running the national side-effect database, detecting safety signals in medicines after market authorization, and translating those signals into actionable guidance for regulators, prescribers, and patients. In EU research, they contribute their unique national infrastructure — a live pharmacovigilance database, patient cohorts, and deep expertise in real-world drug safety monitoring — particularly for vulnerable populations such as pregnant and breastfeeding women. They sit at the intersection of clinical data collection, regulatory science, and patient safety communication.
What they specialise in
ConcePTION (2019-2024, €866K) is specifically focused on building a European ecosystem for monitoring and communicating medication safety in pregnant and breastfeeding populations.
WEB-RADR 2 (2018-2020) involved mobile technology approaches to adverse drug reaction reporting, an area where Lareb contributed as a national reporting hub.
ConcePTION keywords include biobank, outcome measures, and predictive models, indicating Lareb is developing capacity in data-driven safety signal prediction.
How they've shifted over time
In their earliest H2020 engagement (WEB-RADR 2, 2018-2020), Lareb's contribution was tied to general pharmacovigilance reporting infrastructure — specifically the digitization and mobilization of adverse event reporting with no documented specialization keyword. By 2019, their focus sharpened dramatically toward a specific and underserved gap: medication safety in pregnancy and lactation, a population largely excluded from clinical trials and therefore dependent entirely on post-market real-world surveillance. The ConcePTION project also introduced methodological depth — biobanks, outcome measures, and predictive models — suggesting Lareb is building not just data collection capacity but analytical and modelling capability in this niche.
Lareb is moving from general national pharmacovigilance infrastructure toward becoming a specialist European hub for medication safety in pregnancy — a high-regulatory-priority, data-scarce area where their real-world patient cohorts are a rare and valuable asset.
How they like to work
Lareb participates exclusively as a consortium member and has never led an H2020 project, which is consistent with their role as a national data and expertise contributor rather than a research coordinator. Despite only two projects, they have engaged with 73 unique partners across 22 countries, indicating involvement in large, multi-stakeholder consortia typical of IMI (Innovative Medicines Initiative) and RIA projects. This suggests they are a sought-after specialist node — brought in for their national database access and pharmacovigilance credentials — rather than a project-building institution.
With 73 unique partners across 22 countries from just two projects, Lareb's network is disproportionately large for its project count, reflecting the broad multi-national consortia of IMI-funded pharmacovigilance research. Their network spans most of Western and Northern Europe, consistent with EU drug safety regulatory networks.
What sets them apart
Lareb holds a structurally unique position as the official national pharmacovigilance centre of the Netherlands, meaning they are the authoritative custodian of Dutch adverse drug reaction data — something no other Dutch research institution can replicate. Their specific focus on pregnancy and lactation pharmacovigilance addresses one of the most persistent data gaps in European drug safety, making them a natural partner for any consortium targeting regulatory science, maternal health, or real-world evidence generation. For businesses developing drugs, diagnostics, or digital health tools in reproductive medicine or drug safety monitoring, Lareb offers both credibility and access to a unique patient population dataset.
Highlights from their portfolio
- ConcePTIONThe largest and most defining project (€866K, 2019-2024), this IMI2-funded initiative positions Lareb at the center of a European effort to build the first systematic ecosystem for monitoring medication safety during pregnancy and breastfeeding — a regulatory blind spot affecting millions of women.
- WEB-RADR 2Lareb's entry into EU collaboration via a digital pharmacovigilance project, demonstrating their role as a national reporting hub capable of integrating mobile and web-based adverse event technologies into national surveillance systems.