On 24 October 2019, EUCROF Paediatric Working Group organised a F2F training on “Essentials of paediatric clinical research” held at the Centro Nacional de Invesigaciones Oncológicas in Madrid.
The meeting provided the occasion to give an overview of the current regulatory landscape for paediatric research, review specific and most important challenges with corresponding solutions in paediatric drug development.
The event intended to train the participants on the main ethical and regulatory issues of paediatric clinical research, informed consent and assent process as well as on specific protocol considerations and safety specifications on paediatrics clinical studies.
The importance of interactions and relationships among the different Paediatric Research Networks and Infrastructures was one of the important points of discussion addressed during the meeting, presented by the TEDDY Network Coordinator Donato Bonifazi, member of the EUCROF Paediatric Working Group (WG), who described the TEDDY Network and its role in the European landscape of paediatric research and within the coordinating group at Enpr-EMA (European Network for Paediatric Research at the European Medicines Agency).
He presented the efforts of TEDDY Network to bring together subjects involved in paediatric drugs development processes, by raising and analysing children diseases specificities and unmet needs with a multidisciplinary approach, promoting integration of basic and developmental research with clinical research to accelerate the availability of paediatric medicines, devices and innovative therapies on the market, addressing ethical, legal, social and regulatory issues of research, engaging children and young patients in decisions related to clinical research and healthcare.
He explained how the European framework recently led to the initiation of two EU funded projects, c4c (European Network for Paediatric Clinical Trials) and EPTRI (European Paediatric Transnational Research Infrastructure), which may represent and integrate all the components of the paediatric medicines development process in a wide infrastructure with a single identity in Europe.
For further information about the event, please visit the EUCROF website.
