With the European Health Data Space (EHDS) regulation set to reshape access and secondary use of health data across Europe, pharma faces both opportunity and complexity. This workshop will provide a deep dive into how different geographies are preparing for EHDS, the practical lessons from the Nordic Valo Project pilot, and what these developments mean for RWE generation and regulatory engagement across Europe.

This workshop will gather experts to discuss:

• Breaking Down EHDS Timelines & Scope & Opportunities for Biopharma – What to realistically expect between now and 2028, and how will timelines for access, quality requirements, and cross-border use evolve? What are the main opportunities for Pharma and Mid-Biotechs with EHDS regulation?
• The Valo Project in the Nordics – How a pharma-led initiative is pioneering a “mini-EHDS” model, what’s been achieved so far, and practical learnings for broader European adoption
• Germany’s National Health Data Infrastructure – Early insights into one of Europe’s largest national databases, challenges in governance, and expected implications for pharma
• Balancing Country-Level Systems with EHDS Requirements – Opportunities and risks of overlapping national and EU-level frameworks
• Operational Readiness for Data Access – How to build internal processes, partnerships with hospitals, and technical infrastructure to shorten timelines from ideation to results once EHDS is live
• Data Quality in the EHDS Era – What standards will EHDS enforce, and how can pharma prepare systematic frameworks to ensure data is research-grade from the start?