Post-authorization safety (PAS) studies play a crucial role in ensuring the ongoing safety and effectiveness profile of pharmaceuticals after regulatory approval.
The PAS studies monitor products in real-world settings, identifying rare or long-term adverse effects and vulnerable patient populations. Therefore, PAS studies are essential in contributing to a dynamic understanding of a product’s safety profile and optimizing its use.
With the availability of versatile health data and extensive longitudinal follow-up, the Nordic registry data offers an optimal setting to conduct PAS studies. In the latest episode of Expert Opinions, MedEngine’s Senior Consultant Simone Møller Hede shares her insights on PAS studies and explains why the Nordics provide unique opportunities for such research.
“PAS studies are essential in contributing to a dynamic understanding of a product’s safety profile and optimizing its use.”
At MedEngine, we have specialized in conducting PAS studies for the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA) in the Nordic setting. If you are interested in hearing more, please drop us a note at firstname.lastname@example.org or contact our CEO Tero Ylisaukko-oja.
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