Operationalize Access From Strategy to Execution
The Operationalize: Expanded Access Programs Summit brings together leading access, medical affairs, clinical operations, and supply professionals to advance the end‑to‑end delivery of compliant, scalable, and impactful EAPs.
Each year, the summit provides practical frameworks, regulatory clarity, and operational strategies that help teams launch, manage, and transition programs with confidence. Attendees explore how to streamline global operations, optimise real‑world data collection, strengthen supply logistics, and deliver equitable access across diverse regions and therapeutic areas.
Whether you’re designing your first EAP or scaling a global portfolio, you’ll walk away equipped to operationalise patient access with precision, compliance, and purpose.
What You Can Expect:
Operationalizing Expanded Access in Complex Regional Landscapes: Lessons from Central America & the Caribbean
Attendees uncovered how AstraZeneca is tackling the unique regulatory and operational hurdles of launching EAPs across diverse healthcare systems in Central America and the Caribbean. They learnt practical strategies for navigating government and public payer structures, managing high-cost therapies in oncology and rare disease, and building stakeholder trust to strengthen regional access frameworks.
Turning Compassionate Use Data into Regulatory Impact: A Case Study from Regeneron
Attendees explored how Regeneron successfully transformed real-world data from an ultra-rare disease compassionate use program into a foundation for regulatory submission. Gained insights into data collection, validation, and integration challenges - and learnt how cross-functional collaboration turned raw insights into actionable evidence.
Rapid-Fire Solutions: Building Ethical & Compliant Chargeable Access Models
Moved beyond theory in this fast-paced, interactive session designed to test and refine practical paid-access frameworks. Through real-world case studies, explore subscription models, tiered pricing, and co-pay safeguards, and work collaboratively to design fair, compliant chargeable access solutions that align patient need with operational sustainability.
AI in Action: Driving Operational Excellence Across Expanded Access Programs
Discovered how Sanofi is harnessing AI and data analytics to predict supply needs, assess patient eligibility, and flag compliance risks before they escalate. Saw how digital intelligence can reshape program design around unmet needs, optimize global reach, and free up teams to focus on what matters most- timely and equitable patient access.
5 Reasons to Attend the Next Summit With Your Team
Strengthen Global EAP Readiness
Bring your team to align on the latest global frameworks, ensuring your organization can design, approve, and activate EAPs efficiently across multiple geographies - from the US and EU to emerging markets.
Streamline Operations Across Functions
Break silos between Clinical Operations, Medical, Access, and Supply to establish shared processes, improve communication, and reduce delays in program setup and delivery.
Navigate Chargeable Access Models Confidently
Equip your teams to approach paid-for programs with a shared understanding of ethical, compliance, and operational requirements - ensuring access remains transparent, fair, and defensible.
Build Resilience in Complex Supply & Logistics
Learn how leading companies are maintaining supply continuity in unpredictable scenarios through smarter forecasting, vendor partnerships, and digital coordination tools that enhance visibility and control.
Accelerate Learning Through Real-World Case Studies
Gain practical insights from global leaders running EAPs for rare, ultra-rare, and gene therapies - discovering proven frameworks that can be adapted to your own program design and execution.
Explore the 2026 Event Guide
- Navigate global regulatory changes and deliver compliant programs worldwide
- Optimize data collection to balance access, ethics, and evidence
- Harness digital tools and AI to enhance oversight and efficiency
- Build resilient supply strategies to meet unpredictable patient demand
- Streamline collaboration across access, clinical, and supply functions
2026 Speaking Companies
Explore the Agenda
Uncover practical insights from leading access, operations, and medical affairs experts through real-world case studies, interactive discussions, and hands-on workshops designed to help you build, manage, and scale compliant, patient-focused Expanded Access Programs worldwide
Partner With Us
Showcase how your solutions empower sponsors to operationalize access - from supply chain and digital workflow tools to regulatory consultancy and real-world data systems
Join the Global EAP Community
Be part of the only meeting uniting 140+ access leaders across pharma, biotech, and service providers. Exchange practical experience, shape global best practices, and collaborate on solutions that advance equitable, ethical, and scalable access for patients in need
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