Navigate Complex Regulatory, Supply & Operational Hurdles to Streamline Patient Access, Optimise Compliant Evidence Generation, & Operate Successful EAPs in Chronic & Rare Diseases
Welcome to the 4th Operationalise: Early Access Programmes Summit Europe
Improving Global Access to Life Changing Therapeutics
When patients can't afford to wait, Expanded Access Programmes become a vital lifeline. With growing demand in rare diseases, oncology, and advanced therapies - and increasing expectations from regulators, physicians, and patients - the pressure to execute programmes effectively has never been higher. With 18 of the 27 EU countries having their own compassionate use guidelines, access teams are navigating a complex and high-stakes landscape. Faced with inconsistent regulations, limited internal resources, and heightened scrutiny over compliance, data, and supply, success demands precision, collaboration, and expertise.
Join 120+ leaders from Access, Clinical Operations, Medical Affairs, Regulatory, and Supply Chain at the 4th Operationalise: Early Access Programs Summit Europe, the only forum designed to tackle these realities head-on. Whether you’re navigating access for the first time or scaling a complex, multi-country programme, you’ll leave equipped with practical takeaways, proven frameworks, and peer-led case studies to tackle your biggest executional challenges head-on.
The 2025 World-Class Speaker Faculty Includes:
Annmarie Galli
, Head, Global Medical Affairs Research & Compassionate Use / Managed Access Programs
GSK
Rachel Harrison
Director, Pre-Approval, Post-Trial Access Programmes, Medical Affairs & Evidence Generation
Argenx
Unmissable Highlights:
Navigate Real-World Data Collection in EAPs with Confidence
Gain clarity on what data can and can’t be collected across different countries, how to engage internal teams in post-approval planning, and where real-world evidence can support regulatory dialogue, without compromising program integrity. Learn directly from case studies from GSK and Vifor Pharma.
Master Early Access Execution in Rare Diseases
Explore how biotech leaders like Chiesi, GenSight Biologics, and Sarepta Therapeutics are launching rare disease EAPs with limited resources, managing unpredictable global demand, and preparing for rapid commercialisation - all while maintaining trust with patient groups and regulators.
Build Bulletproof Exit Strategies to Ensure Program Continuity
Set your programme up for long-term success by aligning clinical, supply, and commercial teams from the outset. With insights from Blueprint Medicines, SpringWorks Therapeutics, and ImmunoGen, learn how to manage transitions, avoid patient access gaps, and ensure continuity through approval.
Optimise Quality, Safety & Supply Operations for Seamless Early Access Delivery
Benchmark your operational approach against peers and gain practical solutions for global logistics, scalable SOPs, and streamlined safety reporting. Learn how Boehringer Ingelheim and Pfizer are building robust delivery frameworks for compliant, high-quality early access.
Bridge Internal & External Stakeholder Priorities to Drive EAP Success
Discover how cross-functional teams are working alongside HCPs, patients, and advocacy groups to co-create impactful access programmes. With learnings from Teva and the International Gaucher Alliance, understand how to foster alignment, clarity, and long-term engagement at every step.
What Past Attendees Had to Say:
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Events In the Series:
