On November 29-30, 2018 Warsaw hosted a two-day event on SMART project results and training activities, including special sessions on the ethical and regulatory aspects of the paediatric research, on clinical trials management, paediatric networks and infrastructures.
The meeting was titled “Paediatric Foresight Training Course - Current status and future changes in the European paediatric biomedical research” and has been organized by the Children’s Memorial Health Institute in Warsaw, as project coordinator, and Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus.
All the project partners took part in the event, together with relevant experts from the PDCO, the Polish Office for registration of medicinal products, medical devices and biocidal products, Enpr-EMA and some pharmaceutical companies, such as Angelini.
The meeting was composed of two sessions aimed at presenting the project results, the training activities and the results obtained by the trainees involved in the project. The event also provided an overview of the existing paediatric initiatives around Europe to promote paediatric biomedical research and drugs development.
SMART main challenge was to raise the Children’s Memorial Health Institute staff’s research profile and increase their capacity in providing innovative paediatric research methods such as PK-PD data Modelling&Simulation (M&S), data extrapolation, and suitable dosage forms identification. This has been possible thanks to an articulated training programme created by Consorzio per le Valutazioni Farmacologiche (CVBF, IT), Fondazione Gianni Benzi (FGB, IT), University of Bari (IT), University College London (UK) and Aix-Marseille University (FR), and composed of face-to-face and e-learning courses, summer schools (in Bari and Jachranka), staff exchange periods.
Thanks to the SMART project, the improved know-how in paediatric clinical trials and drug development of the Children’s Memorial Health Institute is expected to increase its chances in assuming a leading role in the European paediatric research scenario, together with the possibility to include the staff in new clinical research activities requiring the acquired competences.