On October 5th, 2018, representatives from EPTRI and the Medicines Evaluation Board (MEB), the Dutch Regulatory Agency, had an informal discussion on the medicine development for the paediatric population, its gaps and need of concrete responses.
The discussion arose following the reception from the MEB of the survey performed in Spring-Summer 2018 in the framework of the EPTRI project which was aimed to collect interest and map potential service providers and research units to be included in the future European Paediatric Translational Research Infrastructure.
Several topics were raised as gaps in the current research framework in need of a concerted response and in alignment with the European regulatory framework. An agreed report from the discussion was issued and is available here.
MEB members provided their opinions on the paediatric drug development starting from leads identified in the specific sub-population stratified by age and relevant biomarkers. The Agency presented also its plans to help the paediatric community in general, mostly through the participation to the international groups and activities organized at the EMA.