Patients involvement in the development of paediatric clinical trials is recognized as an important added value at European and international level and an essential contribution to paediatric clinical research. […]
PARIS (31 January 2017) – The European Clinical Research Infrastructure Network (ECRIN) has announced the launch of the Paediatric Clinical Research Infrastructure Network (PedCRIN). The three-year project brings together ECRIN and the founding partners of the European Paediatric Clinical Trial Research Infrastructure (EPCT-RI) to develop capacity for the management of multinational paediatric clinical trials. Children represent 20% of the European population and their health is a major societal challenge for Europe and the world, requiring the development of evidence-based paediatric medicines and treatment strategies. Yet, there is a current lack of data specific to neonates, infants and children; over 50% of the medicines used in these groups have not been tested on them specifically, but rather, on adults. This is problematic as neonates/infants/children and adults differ widely in many ways, from their physiology to their metabolic pathways. […]
TEDDY, the first paediatric Network of Excellence in Europe, makes the point on research and innovative cares for children
The Italian contribution and the new INCiPiT research network coordinated by the University Paediatric Hospital Bambino Gesù. 2016 is the first year in which a significant increase of new drugs approved by the EMA (European Medicines Agency) for the paediatric population has been observed. There are 36 new molecules now in distribution: drugs for the treatment of HIV also in combination, monoclonal products for haemophilia, the new eltrombopag for immune thrombocytopenia, four new drugs for childhood tumors and 6 orphan drugs for the rare diseases such as the Fabry disease. […]
The last day of the SMART project’s Summer School, organized by Consorzio Valutazioni Biologiche e Farmacologiche moved to Canosa di Puglia, at the headquarters of Farmalabor, an Apulian company founded in 2001 with the aim of enhancing and spreading the culture of galenic formulations. To do so, it manufactures and markets raw materials (active ingredients and excipients), packaging and equipment necessary for the production of galenic drugs by pharmacies, hospitals, and national and international pharmaceutical companies. […]
The paediatric research asserts itself in Europe as a sector of great interest. It was estimated that for the Paediatric Regulation’s effect, the EMA (the European Medicines Agency), has launched about 800 new pediatric clinical trials that will require the involvement of 210,000 pediatric patients in the forthcoming years. […]
International Master In Regulatory Sciences (IMRS) facing the Mediterranean area, an article on Corriere Del Mezzogiorno
On 5th April, 2015, “Corriere del Mezzogiorno”, the special insert of the national newspaper Corriere della Sera, have published an article focused on the launch of the first edition of International Master in Regulatory Sciences (IMRS) facing the Mediterranean countries, sponsored by Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus. The Master, organized in collaboration with the Turkish Ondokuz Mayis University (OMU) and the Community of Mediterranean Universities (CMU), foresees a one year course dedicated to graduates (specialist and master) coming from different disciplines who wish to acquire skills and specific tools in the field of the regulatory activities, by offering a complete and updated training at both European and extra-European. The Master intends to meet the challenge resulting from the increasing complexity of the regulatory sector, characterized by a highly sophisticated and complex legislative and regulatory system. The aim of the course is to train experts able to act in the whole Mediterranean area and create a common operational background, thus promoting more job opportunities for youngsters. The International Master in Regulatory Sciences represents an instrument of innovative training from both a methodological and conceptual point of view, because all the theoretical training is delivered online through a virtual learning platform. The educational activities will feature lectures and e-learning, seminars and webinars, workshops, self-learning and internships. At the end of the course students will obtain a Diploma of International Master. For more information, please visit the Fondazione Gianni Benzi Onlus website. Here you can read the full article.
Corriere della Sera dedicates its issue “Speciale Salute” to the CVBF and its efforts in the fields of Rare diseases and Paediatrics
On March 1st, 2015 the national newspaper Corriere della Sera published, on its special issue Sezione Salute, an article entirely dedicated to CVBF and its contributions and goals in the fields of rare diseases and paediatrics. The article, entitled “Rare diseases and Paediatrics: the goals of the Consorzio per Valutazioni Biologiche e Farmacologiche – Clinical Trial, development of new methodologies and innovative drugs”, is an interview to Donato Bonifazi (CVBF Managing Director), who has outlined the main areas of interest and the activities undertaken by CVBF. Among the activities and the European initiatives coordinated by the Consortium in the field of the paediatric clinical research, a particular emphasis is given to the two European projects DEEP (DEferiprone Evaluation in Paediatrics) and GAPP (GAbapentin in Paediatric Pain) and the efforts made by both the European and non-European Countries of the Mediterranean area. In this respect, explained Dr. Bonifazi, a special attention is given to Albania, for potentials that this country offers in clinical research (and especially in paediatrics). […]
On February 27th, 2015, the national newspaper Corriere della Sera has published on its section “Corriere Sociale,” dedicated to volunteering and Third Sector, an article on CVBF and its activities in the field of rare diseases and paediatrics. The page describes the four main focus areas of the Consortium: Clinical Trials (promotion of an ethical use of medication, ethics and regulatory counselling, organisation and conduction of clinical trials, pharmacovigilance services, CRO and CME providers activities and drug management), Regulatory Consultancy (whose value lies in the set of competencies guaranteed by the consortium members), Scientific Research (in particular paediatric clinical research, conducted in the context of European projects), Training (with particular regard to the DEEP project and its significant contribution in the field of paediatric research, with the aim of making the iron chelating agent deferiprone- DFP, available in a new formulation specifically tested for children with β-thalassaemia and other transfusion dependent haemoglobinopathies). Here you can download the complete article.
CVBF, partner of the Gianni Benzi Pharmacological Research Foundation and the paediatric clinical research activities carried out through its DEEP project have been the object of an article published on “Il sole 24 ore – Eventi Sud” on 20th October with the title “CVBF – Innovazione nella ricerca clinica pediatrica” (CVBF – Innovation in paediatric clinical research). Donato Bonifazi, CEO of CVBF and Project Manager of one of CVBF main paediatric projects, DEEP (DEferiprone Evaluation in Paediatrics) has highlighted its value: “The DEEP project will also lead to the collection of information intended for regulatory purposes and may thus provide an important contribution to paediatric research in giving the opportunity to many children in the world to have a new syrup specifically tested for them “. […]
Pavia, November 25th, 2013. The first European project on paediatric chronic pain and the expression of a collaborative effort involving pharmacologists, clinical neurologists and paediatricians from 9 different European and extra-European countries, GAPP – GAbapentin in Paediatric Pain was officially kicked-off at the premises of Cascina Scova in Pavia, Italy, on November 18-20th 2013. […]