Pre-Conference Day

This hands-on workshop moves beyond AI theory and puts attendees directly into the RWE study lifecycle. Working through practical use cases, participants will explore how AI can be applied across protocol development, statistical planning, data abstraction and evidence generation, while navigating the validation, confidentiality and regulatory challenges that come with implementation. By the end of the session, attendees will have practical prompts, tools and frameworks they can take back to their teams and apply to their own RWE programmes.

Attend this workshop to:

• Work through the RWE study lifecycle and identify where AI can meaningfully accelerate processes without compromising scientific rigour or regulatory requirements.
• Develop and test practical AI prompts and workflows for protocol development, statistical analysis planning and medical record abstraction.
• Build approaches for validating AI-generated outputs, establishing appropriate gold standards and maintaining human oversight before evidence reaches regulatory submission

With EHDS moving from regulation towards implementation, the challenge for RWE teams is shifting from understanding what the legislation means to preparing for how data will actually be accessed, reused and governed across Europe. This interactive workshop will put attendees in the role of RWE strategists, working through realistic data access scenarios to navigate different national requirements, data holders, contracting models and ethical considerations. By the end of the session, attendees will have practical frameworks to assess data-access routes, anticipate country-level barriers and build more efficient strategies for future RWE programmes.

This workshop will gather experts to discuss:

• Work through real-world data access scenarios involving registries, hospitals, academic institutions and patient organisations to identify potential bottlenecks before studies begin and build a practical framework for assessing data-access routes across European countries, including regulatory, ethics, contractual and commercial considerations.
• Develop strategies for negotiating with diverse data holders and establishing clearer expectations around access, payment, data use and timelines.
• Identify the internal processes, partnerships and infrastructure RWE teams should start building now to be operationally ready as EHDS implementation progresses.