The official podcast of the European Medicines Agency. This series takes you behind the scenes of medicines regulation in the EU, exploring the science and the experts working to ensure medicines for humans and animals are safe, effective, and of high quality.
Inside EMA
Claim This Podcastby European Medicines Agency
9 episodes
Updated Daily
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Podcast Overview
The official podcast of the European Medicines Agency. This series takes you behind the scenes of medicines regulation in the EU, exploring the science and the experts working to ensure medicines for humans and animals are safe, effective, and of high quality.
Language
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Publishing Since
11/18/2025
1 verified contact email on file for Inside EMA
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Recent Episodes
July 27, 2026
Better science, better medicines: how innovation is reshaping animal testing
<p>Could medicines one day be developed without animal testing? Scientific innovation is advancing rapidly, and momentum is growing in Europe and globally to reduce andultimately replace the use of animals in research. The EU has launched a roadmap towards phasing out animal testing for chemical safety assessments, and EMA continues to build on its longstanding commitment to the 3Rs principles (replace, reduce, refine animal use). Working with partners across Europe and internationally, EMA is helping drive this transition, supporting the development of alternative approaches that protect both science and patient safety.</p><p> </p><p>In this episode of Inside EMA, Stefano Ponzano, Head of EMA’s Office of Translational Sciences, discusses the future of animal testing in medicines development and regulation. He explores the role animal studies have traditionally played, explains the challenges and opportunities of moving beyond them, and highlights how innovative methods could not only reduce animal use but also generate more human-relevant data to improve medicines development.</p><p>Related documents: </p><ul><li><a href="https://eur04.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.ema.europa.eu%2Fen%2Fhuman-regulatory-overview%2Fresearch-development%2Fethical-use-animals-medicine-testing&data=05%7C02%7CVladimira.Yalmanova%40ema.europa.eu%7Cebe792b1c6c34ff1584508deebb270ce%7Cbc9dc15c61bc4f03b60be5b6d8922839%7C0%7C0%7C639207348795118089%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=PptuW7pgeqzs0fEapEFlEhMOCQbPPx5Lyfsto0O6G%2Bk%3D&reserved=0">Ethical use of animals in medicine testing | European Medicines Agency (EMA)</a> </li><li><a href="https://eur04.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.ema.europa.eu%2Fen%2Fhuman-regulatory-overview%2Fresearch-development%2Fethical-use-animals-medicine-testing%2Fregulatory-acceptance-new-approach-methodologies-nams-reduce-animal-use-testing&data=05%7C02%7CVladimira.Yalmanova%40ema.europa.eu%7Cebe792b1c6c34ff1584508deebb270ce%7Cbc9dc15c61bc4f03b60be5b6d8922839%7C0%7C0%7C639207348795131141%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=0skJUYycOQIj7s%2FOucdNCiIZ5E2Q6PXLAb%2F5xnSb5KU%3D&reserved=0">Regulatory acceptance of new approach methodologies (NAMs) to reduce animal use testing | European Medicines Agency (EMA)</a></li></ul><p><br></p>
June 23, 2026
Evidence for two: medicines in pregnancy and breastfeeding
<p>Up to 90% of women who are pregnant or breastfeeding use medicines, yet for many of these treatments, reliable safety data remains limited. Why does this gap exist—and how can it be addressed?</p><p>In this episode of Inside EMA, Corinne de Vries, EMA lead on medicines in pregnancy and breastfeeding, explores the challenges of generating robust safety evidence for these populations. She explains how traditional approaches to clinical research have contributed to the lack of data and why it’s essential to rethink the inclusion of pregnant and breastfeeding individuals in clinical trials.</p><p>Corinne also shares how regulators and researchers are working to generate better evidence throughout a medicine’s lifecycle. Strengthening this knowledge base is key to empowering mothers and healthcare professionals to make informed, confident decisions about treatment—supporting both maternal health and the wellbeing of their babies.</p><p></p>
May 28, 2026
Data, trust and the future of medicines
<p>From clinical trials to real‑world evidence. How is data shaping the future of medicines?</p><p>Discover how EMA uses data to guide safer, better decisions. </p><p> </p><p>In this episode of Inside EMA, we explore how different types of data are shaping the future of medicines regulation in Europe. </p><p>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.</p><p> </p><p>Learn more:<br>•<a href="https://catalogues.ema.europa.eu/catalogue-rwd-studies" target="_blank" rel="noopener noreferer"> HMA–EMA catalogue of real-world data studies</a><br>• EMA paper on <a href="https://ascpt.onlinelibrary.wiley.com/doi/full/10.1002/cpt.70107?af=R" target="_blank" rel="noopener noreferer">Excellence in clinical evidence</a><br>• EMA vision on <a href="https://ascpt.onlinelibrary.wiley.com/doi/10.1002/cpt.3596" target="_blank" rel="noopener noreferer">Real-world evidence</a><br>• <a href="https://www.darwin-eu.org/" target="_blank" rel="noopener noreferer">DARWIN EU network</a></p>
9 total episodes available
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- What is Inside EMA?
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This podcast updates daily.
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This podcast is available on 4 platforms including Apple Podcasts, Spotify, and more. You can also use the RSS feed directly.
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Yes, this podcast regularly features guests.
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