Europe’s Competitive Edge: The Regulation & Reform Impact

Europe’s clinical trial landscape is at an inflection point. EU CTR implementation, IVDR requirements, evolving EMA guidance, expedited regulatory pathways in the EU and UK, and competitive pressure from global regions are reshaping how sites, sponsors, and regulators interact. Regulatory experts and site leaders will examine what is working, what remains fragmented, and what it will take to ensure Europe remains a destination of choice for clinical trials. Spain’s fast-track model, non-EU country comparisons, and the EU Biotech Act implications for sites will all be discussed, with a focus on moving from diagnosis to action.

Speakers

Dana Kudrnova

Natalia Ayas Montero