Mirke Turunen, Head of IT at Fimea, Sami Koskivaara, Account Director at Solita reflect on the the journey from four failed attempts to ultimately happy users and international recognition of a solution for new National register of adverse reactions for FIMEA (equivalent of Läkemedelsverket)

Even in complex, regulated environments like public health, transformative results can be achieved through thoughtful approaches. Fimea’s modernization of its Hava system for reporting adverse reactions highlights how agile methods and strong partnerships can deliver exceptional outcomes.

Fimea replaced an outdated system with a cloud-based platform, becoming a leader in digital transformation among public authorities. By prioritizing user empathy, iterative development, and seamless teamwork, the project cut manual tasks by 50%, improved efficiency, and enhanced pharmaceutical safety—all while gaining international recognition.

Central to Fimea’s success was the FimeaWay operating model, a framework for innovation that fosters transparency, collaboration, and adaptability. This approach shifted organizational culture, reduced siloed work, and captured best practices in the FimeaWay Playbook. By demonstrating how public sector IT projects can achieve outstanding results, Fimea has set a benchmark for excellence in public health and digital transformation.