Inside EMA

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 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.
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.

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
• EMA paper on Excellence in clinical evidence
• EMA vision on Real-world evidence
• DARWIN EU network

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

Obesity rates continue to rise across Europe, but the reasons go far beyond diet and exercise. In this episode, we explore obesity as a chronic disease and look at how weight‑loss medicines like GLP‑1 receptor agonists are influencing treatment and expectations. EMA expert Bart van der Schueren joins us to discuss the biological, behavioural and societal factors that influence weight, and what it means to try to lose weight today.

This episode of ‘Inside EMA’ delves into one of today’s most pressing public health challenges: health misinformation. Konstantina Boumaki, from the European Patients’ Forum EPF), and Steffen Thirstrup, EMA’s Chief Medical Officer, address the rise of health misinformation, the drivers of trust, especially among young people, and the actions EMA is taking to strengthen confidence in medicines and science.