Navigate Regulatory, Supply & Operational Hurdles to Streamline Patient Access, Optimise Compliant Real-World Evidence, & Deliver Scalable EAPs for
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, Early Access, Managed Access, Expanded Access, and Compassionate Use programmes become a vital lifeline. With growing demand across rare diseases, oncology, and advanced therapies - and increasing expectations from regulators, physicians, and patients - the need to execute programmes effectively has never been greater.
This 4th Operationalise: Early Access Programmes Summit Europe brings together professionals responsible for planning and executing early access programmes to share practical, real-world solutions for overcoming operational, regulatory, and compliance challenges. Across three days, you’ll explore how leading organisations navigate:
- Launching and scaling EAPs across multiple regions
- Regulatory and compliance considerations for diverse markets
- Ensure uninterrupted access by optimising supply and logistics in complex programmes
- Harnessing real-world evidence to support regulatory and commercial decisions
- Aligning internal teams and preparing for seamless transitions to commercial launch
With 120+ senior leaders across Access, Clinical Operations, Medical Affairs, Regulatory, and Supply Chain sharing insights and case studies, this summit offers strategies and frameworks that are relevant for any professional involved in designing, managing, or supporting early access initiatives.
The 2025 World-Class Speaker Faculty Includes:
Annmarie Galli
Head of Global Medical Affairs Research & Compassionate Use, Managed Access Programs
GSK
Rachel Harrison
Director, Pre-Approval/Post Trial Access Programs 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:
Our 2025 Partners:
Events In the Series:
