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Artwork for Inside EMA
European Medicines Agency
Antimicrobial Resistance
Misinformation
Medicine Shortages
Glp-1 Receptor Agonists
Darwin EU
Penicillin
Vaccines
Health Communication
Real World Evidence
3rs (replacement, Reduction, Refinement)
Supply Chain
Diabetes
European Health Data Space
New Approach Methodologies
Directive 2010/63/EU
World Health Organization
Covid-19 Vaccination
One Health
Public Health Threats

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.

PublishesMonthlyEpisodes9Founded9 months ago
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MedicineHealth & Fitness

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Artwork for Inside EMA

Latest Episodes

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 towa... more

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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?

In this episode of Inside EMA, Corinne de Vries, EMA lea... more

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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 m... more

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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 ... more

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Recent Guests

Stefano Ponzano
PhD in medicine and chemistry, leads EMA translational sciences; in charge of EMA service
European Medicines Agency
Episode: Better science, better medicines: how innovation is reshaping animal testing
Corinne de Vries
Head of EMA strategy on medicines in pregnancy and breastfeeding
European Medicines Agency
Episode: Evidence for two: medicines in pregnancy and breastfeeding
Peter Arlett
Head of the Data Analytics and Methods Task Force at EMA
European Medicines Agency
Episode: Data, trust and the future of medicines
Denise Umuhire
Real-World Evidence Specialist at EMA
European Medicines Agency
Episode: Data, trust and the future of medicines
Emmanuel Cormier
Head of Regulatory Science and Innovation at EMA
European Medicines Agency
Episode: From idea to medicines: how EMA supports innovation
Bart van der Schueren
Endocrinologist and obesity specialist
KU Leuven, Belgium
Episode: Beyond the scale, obesity in the age of GLP-1s
Dr. Steffen Thirstrup
Chief Medical Officer at EMA
European Medicines Agency
Episode: Inoculated with doubt: misinformation and public trust
Konstantina Boumaki
Medical doctor, patient and diabetes advocate, member of the Youth Group of the European Patients Forum
European Patients Forum
Episode: Inoculated with doubt: misinformation and public trust
Monica Dias
Head of supply and availability of medicines at EMA
European Medicines Agency
Episode: Shortages of medicines: a balancing act

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Better science, better medicines: how innovation is reshaping animal testing
Q: What has EMA already done to promote alternatives to animal testing?
EMA has long supported 3Rs, created a 3Rs working group, established mechanisms for interaction with developers (scientific advice, innovation task force), and developed guidance to ensure methods are scientifically robust and suitable for regulatory use, including reducing non-human primate use where possible.
Better science, better medicines: how innovation is reshaping animal testing
Q: How did you become interested in alternatives to animal testing?
Stefano explains a sustained curiosity throughout his career about innovative methods and a pivotal moment in the lab when early in vitro work suggested that a compound could be tracked and behaved similarly in a living organism, prompting him to explore replacing animals with innovative approaches.
Evidence for two: medicines in pregnancy and breastfeeding
Q: What about breastfeeding research and making information available about transfer into breast milk?
We can design studies that measure the extent of drug transfer into breast milk, encourage safe practices like expressed milk research, and gradually build labeling that reflects real-world evidence for breastfeeding.
Evidence for two: medicines in pregnancy and breastfeeding
Q: How can we act on improving information in pregnancy and breastfeeding throughout the product life cycle?
By integrating data from preclinical studies, clinical development, and post-authorization surveillance, asking for more data from developers, and enhancing product information to reflect current evidence for pregnancy and breastfeeding.
Evidence for two: medicines in pregnancy and breastfeeding
Q: So, maybe to start on this topic, can you explain how you got into it? Why did you get interested in this topic of medicines in pregnancy and breastfeeding?
I got into it during my early years as a pharmacist and researcher, inspired by the thalidomide disaster and the need to learn from history to protect mothers and babies, which led to decades of data collection and regulatory safeguards.

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Frequently Asked Questions About Inside EMA

What is Inside EMA about and what kind of topics does it cover?

The show focuses on medicines regulation, data-driven decision making, and the regulatory ecosystem in Europe. Across episodes, listeners hear from EMA leaders, clinicians, researchers, and patient advocates about how data types beyond traditional trials—from real-world evidence to privacy-aware health data spaces—shape approvals, access, and innovation. Topics routinely cover regulatory tools for innovators, supply chain resilience, public trust, misinformation, and preparedness for future health threats, with concrete case studies on obesity therapies, antimicrobial resistance, and vaccine policy. The program often blends clinical perspectives with policy implications, highlighting practical paths from lab to patient while balancing safet... more

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Inside EMA launched 9 months ago and published 9 episodes to date. You can find more information about this podcast including rankings, audience demographics and engagement in our podcast database.

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What guests have appeared on Inside EMA?

Recent guests on Inside EMA include:

1. Stefano Ponzano
2. Corinne de Vries
3. Peter Arlett
4. Denise Umuhire
5. Emmanuel Cormier
6. Bart van der Schueren
7. Dr. Steffen Thirstrup
8. Konstantina Boumaki

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