Tagged with DKMA

Europe As China and the US attract an increasing share of commercial clinical trials, Europe is fighting to reclaim its spot as a global research leader. While Europe has world-class hospitals and experienced regulators, it has struggled with a complicated and fragmented approval system that has pushed trial sponsors elsewhere. To…

Denmark As Denmark launches its ambitious Life Science Strategy 2030, the Danish Medicines Agency (DKMA), long held as the embodiment of European regulatory excellence, is fine-tuning its priorities. New director Nils Falk Bjerregaard sees the DKMA’s role as a “facilitator of innovation,” supporting early-stage development and leveraging real-world data at home,…

Denmark With a mandate spanning pharmaceuticals, medical devices, and clinical research, the Danish Medicines Agency plays a central role in shaping both national health policy and European regulatory alignment. Under the leadership of Nils Falk Bjerregaard, the agency is navigating a period of accelerated transformation, defined by digitalisation, real-world evidence, decentralised…

Denmark In conversation at DIA Europe 2024 in Brussels, Lars Bo Nielsen lays out the digital transformation that the Danish Medicines Agency has undergone over the past three years and how AI can best be integrated into the work of national regulatory bodies.   What does AI really mean? How can…

Denmark In a wide-ranging interview, incoming director general of the Danish Medicines Agency Lars Bo Nielsen discusses the challenges that personalised medicine presents to regulators, building a stronger international presence for the Agency, and better leveraging the country’s world-class data infrastructure while respecting the EU’s data protection regulation.   Within Europe,…