Paris – June 1st 2021 The PedCRIN (Paediatric Clinical Research Infrastructure Network) consortium will host a final event “Fostering International Paediatric Clinical Research” on June 16th 2021, from 9:30 to 13:00 CEST. The free online event will bring together stakeholders in paediatric and neonatal clinical research to discuss the key outcomes and accomplishments. PedCRIN comes to an end on June 30th 2021 and there is much to share from this project which includes direct support to clinical trials and the development of tools to facilitate clinical research in the paediatric and neonatal communities. The PedCRIN achievement: Investigator Initiated paediatric Clinical trials PedCRIN launched a call for trials in 2017, which provided an opportunity to promote the use of PedCRIN throughout the EU paediatric and scientific community and to engage with several paediatric and neonatal networks of academic clinical investigators interested in multinational clinical trials. The three clinical trials selected by the PedCRIN Scientific Board for PedCRIN funding were from three countries (France, Norway and Ireland) and their extension supported access to 10 European countries. The funded pilot trials have brought the opportunity to evaluate the capability to provide trial management services for multicentre neonatal and paediatric clinical trials, as well as to identify areas of improvement. The PedCRIN achievement: tools for the empowerment of the paediatric research community PedCRIN has developed a collection of tools and procedures to support the setup and management of multinational neonatal and paediatric trials in Europe. These tools have been developed to train and support researchers and clinicians so they can establish, run, and manage both paediatric and neonatal multinational clinical trials in a more effective and easier way. The full collection of tools is available on the PedCRIN [...]
The EU has awarded €9.5m to a ground breaking research project into the treatment of faecal incontinence. The aim of the research is to use revolutionary cell therapy to find a possible cure for a condition which affects an estimated 67 million people in Europe. The funding will go to a consortium of 13 organisations across nine countries called AMELIE (Anchored Muscle cELls for IncontinencE). The project will be co-ordinated by UCL and led by Richard Day, Professor of Regenerative Medicine Technology at UCL. Other partners in the UK include Queen Mary University of London, NHS Blood and Transplant and the charity Bowel Research UK, which will take the lead in patient involvement. The research will be conducted over five years, with separate institutions in the UK, Spain and Portugal taking the lead role at each new stage. The project will focus on taking the patient’s own muscle cells, loading them onto specially designed microcarriers and implanting them into the damaged muscle to promote regeneration and restore normal function. Professor Day said that such regenerative medicine therapy offers hope to many people whose lives are severely impaired by incontinence: “We are tremendously excited by the prospect of the AMELIE project and the potential benefits that may arise from the new therapeutic approach being investigated. “We look forward to working with the exceptional consortium of academics, clinicians, industry and charity partners from across Europe to develop our pioneering regenerative medicine approach for treating this debilitating condition. “This will be a radical and innovative approach never before attempted at such a scale.” Lesley Booth MBE, Director of Research and PPI at Bowel Research UK, said that, whilst the condition is extremely common, it is not much talked [...]
The official presentation of the 25 Factories passed the selection within “Estrazione dei Talenti” (Talents mining) action will be held on January 29th, 2020 in Bari, Italy, at the pavilion of the Apulia Region, Fiera del Levante. The event, organised by the Regional Agency for Technology and Innovation – ARTI, is opened to the audience and the press, and will be attended by the President ot the Apulia Region, Michele Emiliano, and representatives from the regional institutions involved in the action. During the morning session the Factories will provide a brief presentation on their strengths while in the afternoon an infopoint area will be active to provide information to the Teams interested in the entrepreneurship leading programs offerd by Factories. EVOLUTIO START UP Factory which aims at developing business ideas in the r&d, pharm, biotech, medical devices and eHEalth fields will be represented by Paolo Di Silvestro and Bernardetta Maresca from Bioindustry Park, Michele Saviano from CNR and Donato Bonifazi from CVBF – Factory Coordinator. The Programme of the event will be available in the next days.
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). […]