Navigate Complex Regulatory & Operational Hurdles to Improve Global Access to Life Changing Therapeutics

Thank you to our speakers, sponsors, and delegates who joined us in October for the summit! If you are interested in the 2025 event, please register your interest below to receive updates on the meeting!

Operationalise: Early Access Programmes Summit Europe

Improving Global Access to Life Changing Therapeutics

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.

The 2024 World-Class Speaker Faculty Included:

“Really enjoyed working through case studies and thought the workshops and mix of speakers were fantastic”

Christine Eksteen-Ramsden, Director - Medical & Alzheimer Disease, Eisais