Expanded Access no longer sits at the margins of development. As companies launch EAPs earlier – often in parallel with trials, named patient sales, and post-trial access – misalignment is creating regulatory risk, internal friction, and patient confusion. This masterclass establishes a shared foundation for positioning Expanded Access correctly

within the broader access ecosystem and designing first programs that are credible, compliant, and future-proof.

This workshop will gather experts to discuss:

• Clarify where Expanded Access sits within the broader access ecosystem – and where it does explain not fit
• Differentiate Expanded Access, compassionate use, right-to-try, named patient sales, and post-trial access to avoid regulatory and operational missteps
• Design a first EAP with clear intent, governance, and guardrails that withstand internal and external scrutiny
• Align medical, regulatory, clinical, supply, and patient-facing teams from day one
• Build a scalable foundation that prevents rework as programs expand