Day One

• Explore how EMA and FDA are evolving their frameworks and reflection papers to define when and how Real-World Evidence can support INDs, BLAs, and marketing authorisations
• Review recent case examples where RWE successfully contributed to regulatory decisions and what made these datasets “regulatory-grade”
• Discuss how improved data access, standardisation, and global collaboration can help biopharma generate credible, fit-for-purpose evidence accepted by multiple regulators

• Unlock secondary use of hospital data through scalable, privacy-compliant technology
• Build effective collaboration frameworks between data holders, processors, and users to accelerate research access
• Establish viable business models that ensure long-term sustainability and data availability for companies and registries

Kickstart new connections in this speed networking session designed to help you meet a high volume of fellow RWE, RWD, and Medical Affairs experts, exchange insights, and set the stage for deeper conversations throughout the Summit.

• Examine the ethical and compliance considerations of varying physician and patient payments across RWE studies and other related activities (e.g. surveys)
• Explore benchmarks and frameworks that can enhance fair market value to reflect the evolving methodologies/activities used in RWE and align remuneration practices across the industry
• Learn how transparency and standardisation in FMV benchmark databases/data repositories can control costs and reduce complexity, while building trust with regulators, healthcare professionals and patients

• How can pharma, registries, and vendors collaborate to avoid duplication and improve efficiency in finding usable datasets?
• What frameworks are needed to establish fair and transparent remuneration for physicians, patients, and database owners?
• How do we balance sustainability of smaller registries with industry’s need for scale and interoperability?
• How should pharma assess the risks of supporting new registries, and what funding and contracting models best incentivise long-term patient recruitment?
• Where can AI and automation play a role in reducing healthcare system burden and improving data timeliness?

• Scaling Beyond EHDS – How collaborative frameworks like H2O complement the EHDS by enabling cross-border, multi-stakeholder data access and addressing regulatory expectations
• Practical lessons from H2O on capturing patient outcomes in a way that satisfies regulators, HTA bodies, and payers while maintaining patient trust
• Cross-industry data sharing with governance models that make it possible for pharma, providers, regulators, and patients to collaborate on shared evidence platforms

• Learn how tokenisation enables secure patient-level linkage across trial and real-world datasets in the European legal/regulatory context
• Explore practical use cases of data fusion to strengthen causal inference and expand trial relevance and evaluate fit for purpose datasets in Europe for tokenisation linkage
• Discuss challenges in implementing tokenisation in Europe vs. the U.S., and where the opportunities lie for pharma

This is an informal session to help you connect with your peers in a relaxed atmosphere and forge new and beneficial relationships. With an audience of RWE, RWD, and Medical Affairs experts eager to hear the latest innovations and positive movement, you will have the opportunity to display a poster presenting your own work.

• Discover why traditional project-level metrics (e.g. number of studies, publications) fall short in capturing the true impact of RWE functions
• Benchmark emerging approaches to evaluate how evidence planning contributes to launch readiness, market access, and clinical decision-making
• Learn practical strategies to capture long-term impact from shaping prescriber behaviour to influencing HTA/payer decisions, despite gaps in unbiased, representative datasets

• Explore how structured evaluation and data quality frameworks help teams prioritise high-impact RWE initiatives that shape clinical and market access outcomes
• Learn how cross-functional governance models improve ownership, transparency, and accountability for evidence generation throughout the product lifecycle
• Gain practical tools for tracking value beyond activity metrics, from influence on prescriber behaviour to supporting HTA decision-making