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InnoStrat brings expertise to the Early Access Programmes Summit Europe

17 September 2026

InnoStrat will be attending the Early Access Programmes Summit Europe in London on 19–21 October 2026, bringing hands-on experience in Early Access Programmes.

As access programmes become increasingly complex across markets, successful execution requires more than defining an access pathway. It requires clear strategic decisions, strong governance, an effective operating model and alignment across the functions and specialist partners involved.

This is where InnoStrat supports life-science companies.

From strategic decisions to delivered outcomes
Early Access Programmes bring together multiple disciplines, including Medical Affairs, Regulatory, Supply, Legal, Quality, Pharmacovigilance and specialist vendors.

The risks often sit between these functions.

Questions around programme scope, ownership, country prioritisation, supply, data, patient criteria and transition need to be addressed early and governed clearly.

InnoStrat helps sponsors connect these decisions through three integrated areas:

Scope & Governance
We help define the business case, objectives, strategic and risk position, country priorities and governance framework.

Key questions include:

  • What should the programme cover?
  • Who owns the key decisions?
  • How should governance and escalation work?

Operating Model
We help establish the processes, responsibilities and specialist partnerships needed to make the programme operational.

This can include:

  • Specialist vendor selection and liaison
  • Operating workflows
  • Start-up documentation
  • Training and tools
  • Cross-functional coordination

Execution Plan
We translate the strategic direction into a practical plan for execution and oversight.

This can include:

  • Strategic data decisions
  • Oversight and communication planning
  • Patient inclusion and exclusion criteria
  • Patient continuity planning
  • Exit and transition strategy

Together, these three areas create one integrated, execution-ready EAP plan.

Combining industry experience with an independent perspective
InnoStrat’s consultants bring hands-on experience from inside the life-science industry, combined with an independent outside view.

We work alongside internal teams and specialist vendors to help sponsors:

  • Establish clear ownership and decision rights
  • Align cross-functional stakeholders
  • Pressure-test governance and operating models
  • Identify gaps and blind spots early
  • Build scalable capabilities within the organisation

The objective is a connected programme where strategy, governance and execution support each other.

Beyond access: building value into programme design
Patient access remains the primary purpose of an access programme, with safety reporting as a core requirement.

Where appropriate, proportionate programme design can also create opportunities to generate additional insights and evidence, strengthen healthcare networks and improve operational readiness for future stages of the product lifecycle.

InnoStrat can help assess the appropriate role for Real-World Data and incorporate relevant data collection into programme design.

A global EAP setup delivered in six months
InnoStrat recently supported a mid-sized pharma company with limited EAP experience in establishing a global model and preparing for rollout across selected countries.

The starting point included unclear objectives, no formal governance, ad hoc patient requests and complex coordination across specialist vendors.

InnoStrat supported the company with:

  • A global EAP Policy and SOP
  • EAP plan, charter and ICF templates
  • Kick-off scoping and risk assessment
  • An EAP Review Committee and decision pathway
  • Clear roles, oversight and escalation
  • Treatment, safety and data management documentation

The result was a leadership-aligned direction, a scalable and compliant model ready for rollout, and protected patient continuity through a structured handover.

Read the case →

Meet InnoStrat in London
If you are defining, scaling or reviewing a Early Access Programme, we would be happy to exchange perspectives on the strategic and operational challenges you are facing.

Read more about our EAP expertise or book a complimentary 30-minute EAP readiness consultation with Maria Lajer at maria.lajer@innostrat.net

Meet us in London, 19–21 October 2026.

A note on terminology: We use Early Access Programmes (EAP) as an umbrella term for the routes by which patients access a medicine before or outside routine commercial supply. Depending on Country and pathway, these are also referred to as named-patient use, compassionate use (Article 83 and national schemes in Europe), expanded access (21 CFR 312 Subpart I in the US), pre-approval access, or managed access. Where we describe a specific regulatory pathway, we use that pathway’s formal name.