Real-World Evidence (RWE) methods evolve swiftly and regulators like the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) reflect this in RWE guidance documents. Here we review two draft guidelines issued in 2024 by these institutions and extract conclusions on their views towards causality and expected causal inference methodology for non-interventional studies (NIS). Causal inference is recognized as a data science task by the EMA and the FDA in their draft guidelines for RWD. Target trial emulation is considered as a principled framework for RWE generation with increasing support by regulators and RWE research consortia. 

Regulatory Requirements on Causality From The Real World Evidence Draft Guidelines by the EMA and the U.S. FDA: the Target Trial Emulation Framework Checks All Boxes.

Collaborating for Healthcare Innovation – a focus on Sustainability!

18-20 March 2025
Basel, Switzerland

DIA Europe 2025 will focus on sustainability, innovation and collaboration – three key pillars for shaping the future of healthcare. From the environmental impact of pharmaceuticals and of the drug development lifecycle to sustainable partnerships and sustainable healthcare systems, DIA Europe 2025 will be the prime opportunity to discuss how collaboration and innovation can support sustainability in healthcare and each stakeholder’s role in making it happen.

Join us in the vibrant city of Basel for an unforgettable experience, where the power of collaboration will be on full display to inspire actionable outcomes and mobilise for solutions the life sciences’ community. Witness first-hand the profound impact of united efforts, gain valuable insights from across the drug development lifecycle, and play an active role in shaping the future of the pharmaceutical arena.