The Italian Society of Pharmacology (SIF), in collaboration with the University of Trieste and Istituto di Ricovero e Cura a carattere scientifico “Burlo Garofalo” of Trieste, organised the Monothematic Conference “Clinical Trials and off-label in paediatrics: towards the precision medicine” on 26 October 2018 in Trieste (Italy). In the Organizing Committee of the Conference the TEDDY Network was represented by Viviana Giannuzzi, while within the speakers there were Oscar della Pasqua and Francesca Rocchi and the presentation on “Off-label use in paediatrics” was made by Kejla Musaraj, member of the “Off-label” Working Group of TEDDY, who presented an overview of the current scenario on the use of off labels in the EU, underlying the need to update the Summaries of product characteristics (SmPC) with real data coming from paediatric clinical studies.
The aim of the conference was to discuss the issues of drug experimentation in paediatrics, in light of the problem constituted by the off-label use and the need to provide adequate scientific support in this context. Moreover, the great development of molecular diagnostics has promoted the use of concept therapies/precision medicine in several areas including the paediatric field, which however requires ad-hoc experimentation. Such studies, due to specificity of paediatric patients, require the use of innovative methodologies to provide the necessary evidences for the use of drugs.
The agenda of the Conference is available at this link.