In Spring 2022, the International Council for Harmonization (ICH) published the E11A draft guideline establishing a framework for extrapolation from existing data to the pediatric population. The new guideline aims to promote international harmonization of methodologies and strategies to incorporate pediatric extrapolation into overall drug development plans, improving the speed of access to new drugs for pediatric patients while limiting the number of children required for enrolment in clinical trials. The extrapolation framework consists of a pediatric extrapolation concept, and the creation and execution of an extrapolation plan. This workshop has been designed to provide pediatric researchers, trial sponsors, and regulatory reviewers an opportunity to actively engage with experts to learn the fundamentals of developing a pediatric extrapolation concept and plan.
The EFGCP “Better Medicines for Children” Conference is an annual flagship event providing a unique opportunity to share best practice, reflect on what has happened since we last met in October 2021, and discuss paediatric updates with a truly global outreach. The conference will focus on Global Paediatric Development, its challenges and solutions, and in particular on what has been achieved during the pandemic, and the remaining opportunities and challenges. To this effect, the conference brings together not only distinguished speakers from all around the world but also all the stakeholders involved in paediatric drug development.