Explore the Agenda
8:00 am Check-In & Coffee
Track One: Opening Your First Early Expanded Program
9:00 am Workshop A – EAPs 101 – Mapping Access Pathways, Program Types & Execution Models
- Mapping early access, managed access, compassionate use, and post-trial access based on how they operate, not just how they are defined
- Distinguishing program types and what this means for timelines, workload, and risk
- Creating a shared, practical vocabulary that avoids misunderstanding across teams and functions
Track Two: Advanced Challenges in Expanded Access Programs
9:00 am Workshop D – Futureproofing Expanded Access Programs in an Unpredictable Global Environment
- Responding when geopolitical, regulatory or market access changes threaten program continuity
- Maintaining patient access during supply disruptions, sanctions, political instability and changing market conditions
- Building governance frameworks that support rapid, defensible decision-making during periods of uncertainty
- Learning how organizations have successfully adapted programs when the assumptions they were built on no longer held true
10:30 am Morning Break & Networking
11:00 am Workshop B – Building SOPs, Governance Structures & Internal Alignment for New Expanded Access Teams
- Defining ownership across Medical, Regulatory, Clinical Operations and Supply
- Determining which clinical trial processes should be adapted for EAPs
- Building governance structures and approval workflows
- Securing internal buy-in and managing cross-functional stakeholders
11:00 am Workshop E – Delivering Access in Countries Where You Never Intend to Launch Commercially
- Determining when access should be offered in markets with no future commercial pathway
- Balancing ethical obligations, affordability and long-term sustainability
- Navigating free-of-charge, paid-for and hybrid access models
- Managing patient and physician expectations when commercial access will never be available
12:30 pm Lunch Break & Networking
1:30 pm Workshop C – Understanding the Risks, Opportunities & Responsibilities of Collecting Data Within Expanded Access Programs
- Understanding what data can and cannot be collected within an Expanded Access Program
- Determining when data collection adds value versus unnecessary program complexity
- Understanding the potential regulatory, access and evidencegeneration implications of collecting real-world data
- Learning from organizations that successfully introduced data collection into programs from the outset
1:30 pm Workshop F – From Access to Exit: Designing Global Program Closure, Patient Transition & Long-Term Access Strategies
- Navigating country-by-country closure requirements, reimbursement delays and differing patient continuity obligations across global markets.
- Determining how and when programs should close in markets where launch plans, regulatory outcomes or funding assumptions change.
- Learning from successful and unsuccessful program exits, including the operational, regulatory and stakeholder challenges that emerge once an access program reaches the end of its lifecycle.
- Benchmarking how organizations are handling program winddown, patient communications, physician engagement and long-term access commitments globally