OVERVIEW

European Forum for Good Clinical Practice (EFGCP) Better Medicines for Children Conference 2025 is organized by European Forum for Good Clinical Practice (EFGCP) and will be held from Oct 21 - 22, 2025 at Hotel NH Amsterdam Schiphol Airport, Amsterdam, North Holland, Netherlands.

Description:
The conference will focus on “Innovation in paediatric drug development as a driver for change”. At the heart of the Conference lies a resolute commitment to patient-centricity—placing the voices, needs, and lived experiences of children and their families at the forefront of paediatric research and innovation. The conference will bring together distinguished speakers from all around the world and relevant stakeholders and experts to resolve the most urgent and complex challenges in paediatric drug development.

Day One, will start with a Keynote speech from a parent on the impact of trial participation, experience and solutions for study success. As the conference continues there will be the opportunity to discuss novel approaches to drug development in paediatric chronic kidney disease as well as key opportunities in streamlining global clinical trials. We will continue to unpack the implications of evolving EU legislation with a discussion amongst all stakeholders affected by it. Finally, we will explore the integration of artificial intelligence (AI) and machine learning (ML) in paediatric data ecosystems.

Active engagement of conference delegates will be welcomed in Breakout Sessions to share learnings, discuss challenges, and identify solutions on what could be done to optimise children’s access to new medicines, with a focus on these important topics:

1. Pediatric Extrapolation.

2. Innovative approaches in clinical trials for small populations.

3. Paediatric medical devices.

At the end of Day 1, there will be the opportunity for an EMA PDCO member to share their views and perspective on paediatric drug development and also on the EMA Paediatric Committee (PCDO) work.

Day two will start with the feedback and key deliverables from the Breakout Sessions. Then it will be the opportunity to engage on the status of Europe as a competitive/innovative region for paediatric research with a panel of experts including regulators from various regions, such as Europe, the UK, Canada and Japan. Further to this session, there will be two sessions that will focus on Optimising the Clinical Development Path of Orphan Medicines and also on Drug Repurposing, highlighting the outcomes of several projects and real-life examples that enhance delegates expertise in these fields. These sessions will be then complemented by Global Regulatory Alignment and the critical role of these partnerships in derisking drug development. Finally, as a conference first we are proud to present New voices in Paediatric Research with a focus on real world examples of successful paediatric drug development.