Improving Global Access to Life Changing Therapeutics
The 5th Operationalise: Early Access Programmes Summit Europe is where teams go beyond theory to understand how early access is actually delivered in today’s complex environment.
Across three focused days, expect 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.
Leave with the clarity, confidence, and practical strategies needed to execute effectively and deliver timely access for patients when it matters most.
Unmissable 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.
Divide & Conquer: Tailored Learning for Every Stage
Whether you're building your first Early Access Programme or managing complex global delivery, our dedicated workshop day is designed to meet you where you are. Split into two focused tracks, this is your opportunity to develop foundational understanding or tackle advanced operational challenges alongside your peers.
Track 1: Building Your First Early Access Programme
Build the foundations to design and deliver effective programmes
Designed for those newer to the space or setting up early access for the first time, this track focuses on understanding programme types, mapping pathways, and establishing structures that are operationally viable from day one.
Key Sessions Include:
- EAPs 101 – Mapping Access Pathways, Programme Types & Execution Models
- Structuring Programmes That Remain Controllable Over Time
- Running EAPs Day‑to‑Day – Handling Operational Reality Without Losing Control
Track 2: Advanced Challenges in Early Access Programmes
Address the realities of scaling, complexity, and global delivery
Built for experienced professionals, this track is focused on tackling the most complex, real-world challenges in early access, giving you the space to pressure-test your approach, learn how peers are navigating increasing operational demands, and strengthen how you manage programmes as they scale in complexity and scrutiny.
Key Sessions Include:
- Managing Early Access Programmes During War, Crisis & Systemic Disruption
- Operationalising Informed Consent & Physician‑Led Responsibilities Outside Clinical Trials
- Running Global Access Programmes Through Distributed Execution & Shared Accountability
Explore the Full Event Guide
- Get a Full Overview of the Agenda, Speakers, and Session Topics in One Place
- Share Easily With Your Team to Assess and Mobilise Interest
- Discover Unrivalled Networking Opportunities With 140+ Leaders Across Medical Affairs, Regulatory, Clinical Operations, and Supply
- Explore Attendee Benefits, Exclusive Event Insights and Anticipated Audience Metrics
- Learn More About Europe’s Only Forum Dedicated to the Operational Reality of Early Access
Attending Companies Include
Explore the Agenda
Discover exactly how leading teams are solving the hardest Early Access challenges - from pathway selection and global delivery to data, supply, and long-term sustainability.
Partner With Us
Position your solutions in front of decision-makers actively looking to scale and optimise Early Access Programmes, and become a trusted partner in delivering access worldwide.
Join Early Access Leaders
Connect with the EAP community shaping how access is delivered today, exchange real challenges, and learn directly from peers running programmes across global markets.