Real-World Evidence on Pharmaceuticals: UiO seminar showcases the power of Norwegian health data

On 12 February 2026, researchers, students, and industry partners gathered at Ole-Johan Dahls hus for the seminar “Real-World Evidence on Pharmaceuticals – capitalizing on Norwegian health data”. The event highlighted the breadth of real-world evidence (RWE) research at the University of Oslo, spanning drug utilization, effectiveness, and safety studies of pharmaceuticals and vaccines.

Showcasing UiO’s real-world research data pipeline

The seminar opened with an overview of real-world studies at UiO and how Norwegian health registries enable large-scale analyses of treatment effectiveness, rare adverse events and patient-specific risk profiles. The session placed special emphasis on how the emerging Life Science building and new data analytical pipelines at UiO will further expand capacity for data-driven research on pharmaceuticals and vaccines.

Prof. Hedvig Nordeng, head of the PharmaSafe research group, presented UiO’s growing portfolio of RWE studies and convergence environments. With more than 20 years of experience working with Norwegian health registry data, she will lead the UIORealWorld Evidence convergence environment in the new Life Science building and serves as an EU Commission–appointed independent scientific expert member of the PRAC at the European Medicines Agency

A lecture audience watches a presentation on generating real‑world evidence from real‑world data. The projected slide contains diagrams showing data sources, transformation into a common model, and standardized analytics. A presenter stands beside the screen.
Photo: Private

Speakers: from regulatory RWE to integrated data sources

The scientific programme brought together leading national and international experts to address key dimensions of RWE on pharmaceuticals:

  • Real-world studies at UiO – capitalizing on Norwegian health data: Prof. Hedvig Nordeng introduced UiO’s strategy for leveraging registry data, multidisciplinary expertise and new analytical pipelines to produce high-quality RWE relevant for regulators, clinicians and public health.

  • Real-world studies for EU regulatory decision-making: Prof. Daniel Morales, clinical epidemiologist and Professor of Primary Care at the University of Edinburgh, discussed how federated analytics and RWE are increasingly used by the European Medicines Agency (EMA) and other regulators. Morales has served as a European Commission–appointed Independent Scientific Expert to the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) and works closely with EMA in the area of RWE.

    A group of attendees sits facing a presentation screen showing a slide titled “Advantages of federated networks” from the University of Edinburgh. The slide includes icons representing sample size, consistency, and generalizability, along with a collage of diverse illustrated faces. A presenter stands at a podium to the right.
    Photo: Private
  • Pandemic preparedness: modelling vaccine effectiveness: Prof. Jon Michael Gran, professor of biostatistics at UiO and PI in the UIORealWorld Evidence convergence environment, presented current developments in causal inference and survival/event history methods for real-world vaccine effectiveness and pandemic preparedness.
A classroom-style lecture room with several attendees seated and facing a large projection screen. The slide on the screen lists research questions related to vaccine effects. A presenter stands at the front, pointing toward the screen while speaking.
Photo: Private
  • Integrating clinical trial and health registry data to study real-world drug effectiveness: Dr. Kristina Gervin, senior researcher at Oslo University Hospital with a secondary position at the Department of Pharmacy, UiO, showed how pharmaco-omics and registry data can be combined to explore genetic and molecular mechanisms underlying neurological disease and drug response, and to study real-world drug effectiveness.
  • A lecture room with attendees seated at tables, looking toward a projected slide titled “The UiO-RWE Convergence Environment bridging RCTs and real-world data.” The slide is divided into colorful sections illustrating patient material, biomarker discovery, and clinical translation. A presenter stands near the podium.
    Photo: private
  • RWE and partnerships with the pharmaceutical industry: Dr. Trond Methi, pharmacist, PhD, and Medical Director at Novo Nordisk Norway, highlighted ongoing and planned RWE collaborations using Norwegian health registries to study pharmacological treatment of obesity and related therapeutic areas.

Together, these talks illustrated the full RWE pathway: from academic methods development and registry-based studies, through integration of trial and real-world data, to regulatory use and industry collaboration.

Poster exhibition: from clinical questions to cutting-edge methods

A poster exhibition showcased ongoing UiO real-world studies and methodological innovation:

Posters on real-world studies from UiO included work on:

  • DARWIN studies
  • Baseline rates of adverse events of special interest (AESIs)
  • HPV vaccine effectiveness
  • Influenza vaccine effectiveness
  • NSAIDs, contraceptives and venous thrombosis (VT)
  • JAK inhibitor (JAKi) drug utilization
  • ADHD drug utilization
  • Opioids drug utilization
  • HIV in children
  • Antipsychotics in children

These projects demonstrate how registry-based RWE can inform safety surveillance, utilization patterns and effectiveness across diverse therapeutic areas and age groups.

Posters on methods highlighted UiO’s contribution to advanced pharmacoepidemiology and data science:

  • Emulating target trial design for vaccine effectiveness in pregnancy
  • Sequential pregnancy trials and intention-to-treat (ITT) analysis in complex scenarios
  • Incorporating genetic data into pharmacoepidemiological studies
  • OMOPing Norwegian data
  • Drug mapping in OMOP
  • The UiO miscarriage algorithm

These methodological projects are central to ensuring that real-world studies achieve high causal validity, are interoperable with international data networks, and can integrate genetic and reproductive health information in a robust way.

Building a convergence environment for real-world evidence

The event was organized by the PharmacoEpidemiology and Drug Safety (PharmaSafe) research group at the Department of Pharmacy, together with the UIORealArt convergence environment. It also served as a preview of the forthcoming UIORealWorld Evidence convergence environment in the new Life Science building, where multidisciplinary teams will work together on large-scale analyses of Norwegian health data.

By bringing together biostatisticians, pharmacoepidemiologists, clinicians, data scientists and industry partners, the seminar underscored UiO’s ambition to be at the forefront of real-world evidence generation for pharmaceuticals—supporting better decisions for patients, health services and regulators.

Published Feb. 13, 2026 2:52 PM - Last modified Feb. 13, 2026 2:54 PM
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