Day One

• Surfacing the most common “blockers” to access and challenging their validity
• Exploring who gets to define acceptable risk – and whether patients are meaningfully part of that decision
• Creating space for more honest, less risk-averse dialogue across stakeholders

• Examining fragmentation across European early access pathways and the resulting challenges for industry payers and HTA decision making
• Exploring a working theory for greater alignment of early access policies across Europe drawing parallels with emerging EU frameworks such as joint clinical assessment
• Evaluating potential impacts of greater alignment including operational feasibility legal considerations and competitive dynamics across similar therapies

• Understand the regulatory framework, eligibility criteria, and operational requirements for EACT and SAP.
• Understanding the factors that influence Health Canada acceptance, ongoing patient access, and regulatory compliance.
• Applying practical strategies for program design, physician engagement, patient monitoring, safety reporting, and outcome documentation to maximize access and treatment continuity.

This interactive break is your chance to connect with peers, explore real-world experiences, and exchange insights shaping today’s Expanded Access landscape. Use this time to discover innovative approaches, discuss operational and regulatory learnings, and engage with colleagues advancing ethical, patient-focused access pathways. For more information or to share your work, please email info@hansonwade.com

• Discover why patients outside the US & Europe wait years for a therapy that’s already approved elsewhere
• Learn how integrated global planning shrinks the gap between first request and first patient to months, not years — and the six decisions that make it work
• See real case studies across neurology, oncology, and hepatology proving the model scales

• Assessing inherited access programmes against internal standards without interrupting treatment
• Collaborating with partner companies to successfully transition access programmes – managing risk and accountability
• Aligning governance, documentation, and vendors under a new operating model
• Executing post-trial access programmes that have not been planned following an acquisition

• Breaking down what has actually changed in France’s early access and post trial access pathways
• Clarifying misconceptions around what is no longer possible versus what remains feasible with the right authority engagement
• Navigating increased scrutiny, economic paybacks, and stronger justification of medical need under the new rules
• Managing the operational transition from early access or post trial supply into commercial and paid pathways in France

• Understanding what “reimbursement” in an NPS Program really looks like.
• Outlining key design elements of successful for-charge programs
• Highlighting what works in practice

• Exploring what the new EU pharmaceutical legislation introduces for early and compassionate access pathways
• Understanding the opportunities and challenges this creates for industry regulators and patients across Europe
• Highlighting how stakeholders can collaborate to maximise the impact of the new framework
• Setting the foundation for broader discussion on how early access can evolve under this changing regulatory landscape 

• Practical considerations for internal ownership of AAP
• For-charge AAP: setting the price and implications
• Cross-functional coordination between Market Access, Medical Affairs, and Commercial teams in AAP execution
• Navigating surprises during HAS review: lessons learned from unexpected evidence requests, comparator challenges, and assessment outcomes

• Leveraging alternative access routes and managed access pathways across CEE, MENA, and developing markets
• Collaborating with authorities to unlock patient access through flexible and locally adapted solutions
• Balancing patient need, government priorities, and long-term programme sustainability
• Practical lessons from delivering access across diverse healthcare systems and economic environments

• Comparing how FDA, EMA, and national health authorities interpret the use of RWD in expanded and post-trial access programs
• Examining differing company approaches, from limiting programs to treatment-only access to actively incorporating structured evidence generation
• Exploring real-world examples of where regulators accepted or rejected RWD submissions in filings and approvals
• Defining the boundaries of ethical and compliant RWD collection when patient care is the primary purpose 

• Designing data collection approaches that remain within the treatment context and do not interfere with clinical trials
• Identifying what data is truly valuable to collect within EAPs vs where alternative approaches are more appropriate
• Building low-burden, scalable data capture frameworks for physicians and patients
• Translating EAP data into tangible value (e.g. informing safety, dosing, HTA, or prelaunch decision making)

• Discussing a local case study, methodology and publications
• Outlining key learnings and recommendations
• Highlighting EAP RWD collection in Europe, US and beyond

Continue the conversation beyond the conference sessions and connect with peers, pioneers and partners shaping the future of early access programmes. Enjoy an evening of drinks, networking and celebration, with a professional photographer on hand to capture the moments and memories from the summit!