A Clearer Harmony And Attractiveness For EU Clinical Trials Regulation

The EU Clinical Trials Regulation (EU CTR) has been a prominent subject recently, aiming to streamline clinical trial processes across member states by January 2025. In a recent episode of the pharmaphorum podcast, Nicole Raleigh interviewed Chris Bamford, Director of Clinical Trial Regulatory Management at IQVIA, and Shirley Rutter, Associate Director and Strategic Quality Lead at IQVIA Biotech, to discuss industry adaptation to this transition.

Bamford highlights the historical regulatory diversity within the EU and the challenges it posed, while Rutter emphasizes the extensive planning and adaptation required for the new harmonized approach. Despite the complexity, resources such as training and guidance are available, and the EMA has been actively involved. Collaboration and alignment across stakeholders, particularly for smaller biotech firms, are crucial during this transition period. Listen to the full episode for more insights.