Explore the Agenda
8:00 am Check-In & Coffee
Track One: Opening Your First Early Access Programme
9:00 am Workshop A – EAPs 101 – Mapping Access Pathways, Programme 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 programme types and what this means for timelines, workload, and risk
- Creating a shared, practical vocabulary that avoids misunderstanding across teams and functions
11:00 am Morning Break & Networking
11:30 am Workshop B – Setting Up & Structuring Early Access Programmes That Remain Controllable Over Time
- Designing early access programme structures that align with execution capacity, internal workflows, and real-world delivery constraints
- Making deliberate set-up decisions around eligibility, geographic scope, governance, and duration that determine how manageable a programme becomes in practice
- Understanding how early structural choices shape future options for scaling, transitioning, reimbursement engagement, or programme closure
1:30 pm Lunch Break & Networking
2:30 pm Workshop C – Running EAPs Day to Day – Handling Operational Reality Without Losing Control
- Handling incomplete or inconsistent requests from physicians without delaying patient access unnecessarily
- Managing grey areas, deviations, and edge cases that arise outside written procedures
- Differentiating issues that can be progressed within existing processes from those that require escalation or rework
- Building confidence in making pragmatic, defensible decisions while maintaining compliance and internal credibility
4:30 pm End of Workshop Day
Track Two: Advanced Challenges in Early Access Programmes
9:00 am Workshop D – Managing Early Access Programmes During War, Crisis & Systemic Disruption
- Planning access continuity when supply, shipment, or legality changes abruptly due to war, sanctions, or natural disasters
- Defining internal decision-making frameworks for when access must continue, adapt, or stop under crisis conditions
- Managing ethical, legal, and reputational risk when patient need conflicts with external constraints
- Establishing escalation, documentation, and communication approaches for crisis-driven access decision
11:00 am Morning Break & Networking
11:30 am Workshop E – Operationalising Informed Consent & Physician Led Responsibilities Outside Clinical Trials
- Defining what “informed consent” means in treatment focused access programmes rather than research settings
- Clarifying where sponsor responsibility ends and physician responsibility begins in non GCP environments
- Managing variability in how consent is obtained, explained, documented, and revisited over time
- Establishing defensible guardrails to support physicians without crossing compliance or promotional boundaries
1:30 pm Lunch Break & Networking
2:30 pm Workshop F – Running Global Access Programmes Through Distributed Execution & Shared Accountability
- Designing global local operating models where execution is shared but accountability remains clear
- Selecting, empowering, and coordinating country or regional champions without losing programme consistency
- Managing handoffs, communication flows, and responsibilities across global teams, affiliates, and vendors
- Aligning senior leadership on access risk, cost exposure, and long-term obligations in global portfolios