Improving Global Access to Life Changing Therapeutics
The Operationalise: Early Access Programmes Summit Europe was where teams go beyond theory to understand how early access is actually delivered in today’s complex environment.
Across three focused days, there was practical insight on navigating global regulatory variation, managing real-world data decisions, delivering post-trial and early access transitions, implementing paid models, and maintaining supply under uncertainty.
Through real-world case studies, peer-led discussions, and interactive sessions, learn how organisations are overcoming operational challenges, managing risk, and adapting programmes in response to evolving regulatory and commercial pressure.
Attendees left with the clarity, confidence, and practical strategies needed to execute effectively and deliver timely access for patients when it matters most.
Previous Event Highlights
Deliver Early Access During War, Sanctions & Crisis Conditions
Hear from Eisai on how teams are maintaining patient access during war, sanctions, and systemic disruption, balancing ethical responsibility with real operational, legal, and supply constraints when conditions rapidly change.
Respond to MFN Pricing & Evolving Access Expectations
Understand how Novartis and BeOne Medicines are adapting early access strategies in response to MFN pricing pressures and new regulatory guidance, and what this means for governance, timelines, and long-term programme risk.
Onboard & Integrate Access Programmes Without Disrupting Patients
Discover how Genmab and Sobi are successfully integrating and enhancing inherited programmes following organisational change, while maintaining continuity of care and strengthening operational control.
Plan & Execute Post-Trial Access Without Compromise
From early planning with Sanofi to real-world execution with Jazz Pharmaceuticals and Novo Nordisk, learn how to design and deliver post-trial access strategies that avoid disruption, manage supply, and prevent unsustainable commitments.
Make Smarter Real-World Data Decisions
Learn from Bristol Myers Squibb how to define when real-world data adds value, design low-burden collection approaches, and translate insights into meaningful impact, without overcomplicating programme execution or increasing risk.
Navigate Evolving Regulatory Frameworks Across Europe & Beyond
Hear case studies from Lundbeck, ACADIA Pharmaceuticals, and Eisai on operating in Europe’s most complex access frameworks, alongside lessons from delivering programmes across emerging, less-defined markets globally. Interpret shifting requirements, engage authorities effectively, and maintain compliance while adapting to diverse environments.
Attending Companies Included