CORS²

CORS² research spans three interconnected groups, united by a shared commitment to generating actionable evidence for regulatory decision-making and public health.

Pharmacovigilance Research Group (Prof. Morten Andersen)
A Novo Nordisk Foundation funded initiative focused on developing new methods and tools to shape future drug safety surveillance. Research areas include proactive surveillance and signal detection using big healthcare data, multi-database network studies of rare adverse events, and the design of rapid risk evaluation systems. The group actively exploits the Danish National Registers and collaborates through the Pharmacoepidemiology Research Collaboration (PRC) and the Nordic PharmacoEpidemiological Network (NorPEN).

Drug Safety Group (Assoc. Prof. Maurizio Sessa)
Situated at the convergence of applied data science and pharmaceutical science, the group harnesses large and heterogeneous biomedical real-world data, integrating cutting-edge Artificial Intelligence and intelligent automation to advance pharmacovigilance and pharmacoepidemiology. Key research areas include AI-driven causality assessment, signal detection and validation across major spontaneous reporting databases (EudraVigilance, FAERS, VAERS, VigiBASE), applied precision medicine using causal machine learning, and pre-symptomatic care through AI-enabled early detection. The group holds close partnerships with industry and regulatory agencies.

Regulatory Science Group (Assoc. Prof. Christine E. Hallgreen and Prof. Nikolai Constantin Brun)
Focused on interrogating, evaluating and supporting science-driven regulatory decision-making across the full pharmaceutical lifecycle. Research encompasses regulatory methodology, benefit-risk assessment, and the development of frameworks to support robust, evidence-based pharmaceutical regulation in Denmark, the EU, and internationally.