Meeting report on the paediatric high-grade glioma medicines expert workshop

The purpose of the workshop was to help inform the EMA and its Paediatric Committee (PDCO) on how to best compose opinions that set out detailed requirements for non-clinical and clinical paediatric studies, to provide for high-quality Paediatric investigation plans (PIPs) for this group of tumours. The objectives were to learn from invited experts about recent scientific translational developments, to hear about their experience from clinical trials in patients with HGG and to listen to their views on how non-clinical and clinical studies in children with HGG should be conducted. Information on demographics, histopathology, biology and treatments as well as on the relationship between paediatric and adult subsets and between different paediatric subsets was considered, thereby helping to define which data need to be evaluated in order to establish the safe and efficacious use of new medicinal products for HGG in the paediatric population. No confidential information was presented or discussed.