In 2017, the DIA/EFGCP/EMA Annual Paediatric Conference will focus on how to optimise children’s access to new medicines.

With more than 10 years of the EU Paediatric Regulation, all parties involved in paediatric drug development (industry, regulators, academia, healthcare professionals and patients) have seen progress in developing new medicines for children.

This conference will explore how to build on the successes from the past 10 years of EU Paediatric Regulation, and how to overcome challenges that still exist.

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Day 1: 10 years of Paediatric Regulation: Lessons Learnt from All Stakeholders

• Real world examples of what challenges are associated with different regulatory pathways and development scenarios as well as how to overcome them. Case studies will be presented to foster the discussion in rare diseases/small populations as well as oncology
• Discussions on tools and methods appropriate to optimize drug development such as extrapolation
• Concluding session on patient engagement within decision-making processes. What are patients’ groups expectations regarding availability of new medicines and how do they define benefit/risk?

Day 2: Looking Toward the Future

• Updates from ongoing European and International initiatives related to paediatric, including clinical trials
• Discussions on possible opportunities with the new European Clinical Trials Regulation when conducting paediatric clinical trials
• Quest for solutions within paediatric pharmacovigilance with a view to promote shared understanding with all parties
• Concluding sessions on exploring the future of children’s access to new medicines. Different stakeholders face different challenges that are unique to Europe, while paediatric medicines development is global. This session aims to promote a common understanding and alignment on important points from different stakeholders and will set the scene for future dialogue.

There will be a specific Q&A session with EMA on paediatric procedures.