Expanded Access programs have transformed into a vital, yet more intricate, component of pharmaceutical R&D and commercialization plans. Previously a passive route, they now serve as a tactical tool influencing schedules, data collection, and patient availability throughout international territories.
With heightening
regulatory requirements, lengthening reimbursement negotiations, and program footprints expanding into new territories, the demand for more intelligent, proactive, and executionally sound access models is paramount.
To address these needs, the 5th Operationalise: Early Access Programmes Summit Europe stands as the primary gathering for professionals steering these developments. Over 140 specialists across medical affairs, market access, regulatory, clinical operations, supply chain, and real-world evidence are assembling to establish modern standards for early access implementation.
Gain insights straight from executive leaders at UCB, Eisai, Novartis, BeOne Medicines, Alnylam Pharmaceuticals, Genmab, AstraZeneca, Bristol Myers Squibb, Argenx, ACADIA Pharmaceuticals, and other organizations as they reveal the strategic choices, operational models, and practical experiences guiding future Early Access programs.
If a team is designing an initial program, expanding territory coverage, or directing an international access portfolio, this conference offers the chance to measure progress alongside industry-leading organizations.
Explore the full event guide
- Review the complete agenda, speaker list, and session details in a single location
- Pass this information along to colleagues to evaluate and generate interest
- Access unmatched networking events alongside over 140 leaders in medical affairs, regulatory affairs, clinical operations, and supply chain
- Examine participant advantages, special conference details, and expected audience metrics
- Uncover additional details regarding the sole European conference focused on early access operational practices

About 5th Operationalise: Early Access Programmes Summit Europe
Early Access Programmes have evolved into a critical, but increasingly complex, part of drug development and launch strategy. What was once a reactive pathway is now a strategic lever shaping timelines, evidence generation, and patient access across global markets.
As regulatory expectations intensify, reimbursement timelines stretch and programs expand across more regions, the need for smarter, earlier and more operationally robust access strategies has never been greater.
That is why the 5th Operationalise: Early Access Programmes Summit Europe has become the essential meeting point for the teams leading this transformation. We'll be bringing together 140+ experts across Medical Affairs, Patient Access, Regulatory, Clinical Operations, Supply and Evidence Generation to define what best-in-class early access looks like in 2026 and beyond.
Hear directly from senior leaders at UCB, Eisai, Novartis, BeOne Medicines, Alnylam Pharmaceuticals, Genmab, AstraZeneca, Bristol Myers Squibb, Argenx, ACADIA Pharmaceuticals, and more as they share the decisions, frameworks and lessons shaping the next generation of Early Access Programmes.
Whether you are building your first program, scaling across regions, or managing a global access portfolio, this is your opportunity to benchmark against the organisations setting the pace globally.
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