Inside EMA
From clinical trials to real‑world evidence. How is data shaping the future of medicines? Discover how EMA uses data to guide safer, better decisions. In this episode of Inside EMA, we explore how different types of data are shaping the future of medicines regulation in Europe. EMA experts Peter Arlett and Denise Umuhire explain how real-world evidence - data from electronic healthcare records - complements clinical trials to support decisions on the safety and effectiveness of medicines. The episode also looks at DARWIN EU, the Agency’s network for generating evidence across Europe, and how data is used in a secure and transparent way to build trust. Learn more: • HMA–EMA catalogue of real-world data studies [https://catalogues.ema.europa.eu/catalogue-rwd-studies] • EMA paper on Excellence in clinical evidence [https://ascpt.onlinelibrary.wiley.com/doi/full/10.1002/cpt.70107?af=R] • EMA vision on Real-world evidence [https://ascpt.onlinelibrary.wiley.com/doi/10.1002/cpt.3596] • DARWIN EU network [https://www.darwin-eu.org/]
7 episodios
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