Professor Adriana Ceci, member of the Board of Directors of Fondazione Gianni Benzi, participated in the kick of meeting of the Summer School Paediatric peRsonalized ExtemPorAneous foRmulAtions – PREPARA, held on July 25th in Canosa di Puglia.
The Summer School PREPARA is a project organised by the Department of Pharmacy – University of Bari and by Farmalabor srl, in cooperation with the Agenzia per il Diritto allo Studio Universitario della Regione Puglia ADISU Puglia.
Professor Ceci’s speech focused on the lack of paediatric medicines approved in Europe and subsequent off-label use as well as on the limited availability of suitable and innovative paediatric formulations, covering all the age groups. It also underlined the need to implement clinical studies and innovative technologies in the paediatric field, including the repurposing or repositioning of medicines already approved.
Relevant initiatives to cover the gap have been implemented such as the 2006 Paediatric Regulation and the establishment of network and research infrastructures like the European Paediatric Translational Research Infrastructure – EPTRI, coordinated precisely in Apulia region.
Professor Ceci explained that for years, due to the lack of ad hoc studies, many medicines have been administered to trat paediatric condition based on clinical data from adults, compelling children to use unsuitable medicinal products (too large tablets, not acceptable tastes, poor quality home-made solutions), leading to issues related to dosage, efficacy and safety unavoidably. Therefore, to date, the approved paediatric medicines are not able to meet completely the therapeutic needs of paediatric patients.
The Summer School aims to increase knowledge and skills of young researchers and graduates on pre-formulation, formulation studies and studies requested by a regulator. As highlighted by Professor De Nora, director of the Summer School and associated professor at the Department of Pharmacy – University of Bari, and by Doctor Fontana, president of the Board of Directors of Farmalabor, who planned and hosted the kick-off meeting respectively, these skills are useful to know, manage and develop suitable extemporaneous formulations for paediatric conditions for which the approved medicine is lacking.
More details on the School are available here!