Harpreet Ram
President & Executive Director GARDaccess
Seminars
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
As Expanded Access programs scale globally and extend over longer durations, the question of charging for treatment continues to surface – often uncomfortably – inside organizations.
This interactive session explores the ethical, regulatory, and operational arguments for and against charging within Expanded Access, examining:
- When charging is raised as a sustainability lever
- Where it risks undermining patient trust or ethical intent
- What different regions, program types, and disease areas shape the conversation
Through structured discussion and audience participation, attendees will unpack how these decisions are really being debated today
