Inside EMA

Data, trust and the future of medicines

28 min · Gisteren
aflevering Data, trust and the future of medicines artwork

Beschrijving

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/]

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7 afleveringen

aflevering Data, trust and the future of medicines artwork

Data, trust and the future of medicines

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/]

Gisteren28 min
aflevering From idea to medicines: how EMA supports innovation artwork

From idea to medicines: how EMA supports innovation

How does EMA help turn innovative ideas into real medicines? In this episode of Inside EMA, we look at how the European Medicines Agency supports developers from early concepts through to patient access. The discussion highlights how regulation and innovation are not opposites, but complementary forces that help deliver safe and effective medicines. Topics include early scientific dialogue, support for SMEs, and EMA’s engagement with innovation ecosystems across Europe. 🎙️ Featuring Emmanuel Cormier, Head of regulatoryscience and innovation, and Alessandro Faia, Communications officer. Learn more: Opportunities to interact with EMA during the development of a medicine [https://www.ema.europa.eu/en/human-regulatory-overview/research-development#opportunities-to-interact-with-ema-during-the-development-of-a-medicine-38736]

23 apr 202622 min