Increasingly, companies across Europe are recognizing the value of implementing Early Access Programmes to provide patients with access to life-changing medicines. However, challenges remain in adhering to a variety of cross-border regulations, clarifying rules around real-world data collection, and accurately anticipating supply volumes. To overcome these hurdles, it is essential for the industry to collaborate and share solutions.

The 3rd Operationalise Early Access Programmes Summit Europe returned in 2024, dedicated to fostering open dialogue and sharing experiences in navigating the complex regulatory and operational landscape of Early Access Programmes. It gathered a community of over 140 experts in Access, Clinical Operations, Medical Affairs, and Clinical Supply from leading companies such as Novartis, Biogen, Eli Lilly, Gilead, Incyte, and more. Together, country-specific regulatory pathways in Europe and beyond were elucidated, bridging the gap between clinical research and commercial supply, and streamlining access to life-changing therapies outside the clinical trial setting.