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. […]
Six key opinion leaders have been interviewed during the Open Meeting of Tirana and have shared with us their points of view and their direct experiences in contributing in the DEEP study as well as working in a European context. The interviews offer an interesting picture of what the clinical research in Albania has achieved so far and what its legacy will be, in particular in light of a more tight international collaboration within a European research Network, as the DEEP project is. […]
On May 16th, 2015, the city of Bucharest (Romania) hosted the second edition of the European Projects Forum Nextwork, a 2-day meeting aiming to enhance communication in the European projects, strengthen coordination and improve collaboration among local and international partners. On that occasion, project managers and dissemination leaders from EU Member States and neighbouring countries, were invited to reflect on dissemination strategies in order to share qualitative information about European projects. Donato Bonifazi, CEO of CVBF and member of the Steering Committee of the Nextwork Forum, participated in the meeting as speaker in the Foresight “Health & Biotechnology”. His presentation, entitled “GRiP, EnprEMA and Teddy: the European Networks for Paediatric Research”, was focused on networks and organizations of paediatric research and other international initiatives. He highlighted the increasing importance acquired by the paediatric networks in the process of developing high level paediatric research, through the example of the following three networks: GRiP (Global Research in Paediatrics), a Network of Excellence aimed at promoting the availability of drugs for paediatric use and building consensus on international standards, methodologies and tools for paediatric research; Enpr-EMA, the network established at the European Medicines Agency to coordinate the paediatric research networks, aimed at facilitating studies in order to increase availability of medicinal products authorised for use in the paediatric population; TEDDY Network, a European Network of Excellence for Paediatric Clinical Research, aimed at facilitating the performance of good quality paediatric studies and research. […]
The Open Meeting of the DEEP (DEferiprone Evaluation in Paediatrics) project will be held in Tirana at the Hotel Tirana International on May 18th, 2015 DEEP is a 4-year European research Project (FP7) coordinated by CVBF and comprises 28 recruiting sites located in 5 European Countries (Albania, Cyprus, Greece, Italy and United Kingdom) and 5 non-European Countries (Egypt, Lebanon, Marocco, Tunisia and Turkey), 16 scientific partners and a pharmaceutical group based in Canada. The Open Meeting is promoted by Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF) in collaboration with University Hospital Center “Mother Teresa” (UHCT) and will be the occasion to raise the attention on the progresses achieved by the clinical research in Albania and the importance of the European Networks to create synergies to spread excellence and attract European funding. […]
The “Rare Disease Day” campaign has reached its 8th edition this year, on February 28th, bringing once more, to public attention, the topic of rare diseases as a subject of medical, political and institutional concern. The initiative was founded by EURORDIS and its Council of National Alliances in 2008, triggering, ever since, a series of related events all around the globe, fastly turning from an European campaign to a world-renowned advocacy event that stands for dissolving ignorance and empowering collaboration for the better understanding and treatment of rare diseases. “Rare Disease Day” has notably contributed to the advancement of national plans and policies for rare diseases in a number of countries. This year’s theme, “Living with a rare disease”, makes reference to and tries to bring to light and to public appreciation the efforts made by rare disease patients, by their families and friends to cope. The slogan Day-by-day, hand-in-hand of the Official Rare Disease Day 2015 Video evokes the solidarity between families, patient organisations and communities. CVBF welcomes this initiatives by becoming a friend of Rare Disease Day and showing its support on its official website. We proudly join the “Rare Disease Day” manifesto and dedicate all our efforts to improve the healthcare system, also to search, test and provide better treatment and a better handling of these rare diseases.
On December 10th 2014, a press conference was held at the rectorate of the University of Bari Aldo Moro with the aim to sign the framework agreement for the scientific collaboration between the University of Bari (UniBA), the Gianni Benzi Pharmacological Research Foundation (FGB) and the Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF). On that occasion, Prof. Antonio Felice Uricchio as Dean of the University of Bari “Aldo Moro”, Prof. Adriana Ceci as President of FGB and Mr. Donato Bonifazi as CEO of CVBF and Prof. Adriana Ceci as President of FGB undertook to cooperate in carrying out scientific research activities foreseen in the framework of the EU-funded projects (FP7 and Health Programme) in which FGB and CVBF are Partners. In particular, the scientific research activities will involve the following departments at the University of Bari: Department of Biomedical Sciences and Human Oncology; Department of Pharmacy-Pharmaceutical Sciences; Department of Biosciences, Biotechnology and Biopharmaceutical; Department of Basic Medical Sciences, neuroscience and sense organs; Department of Political Science.
The fourth issue of the newsletter pertaining to DEEP-2 clinical trial, one of the three studies at the bottom of the DEEP Project (DEferiprone Evaluation in Paediatrics) was published on January 7th, 2015. This Newsletter highlights the main progresses achieved in the study advancement since July 2014 and provides an overview on the status of the participant experimental sites up-to-date as of the 31th of December 2014, from different points of view (regulatory, monitoring, recruitment). It also includes the Frequently Asked Questions (FAQs) emerged, that are all available on the DEEP website. See the newsletter for more data.
The newly launched “European Reference Networks” Program has recently focused its organisational activities by assembling their first Board meeting on December 5th, which rounded up the official representatives of the Member States. The resolutions of this event involved electing a chairperson and approving regulatory procedures. ERNs are a feature of the EU Directive on Cross-border healthcare and are aimed at uniting the best specialists from across Europe to tackle complex or rare medical conditions that require highly specialised healthcare and a concentration of knowledge and resources. Furthermore, a tender for a Study on the services to be provided by the European Reference Networks and its Members has been published on the 8th of December. The purpose of this contract is to provide a conceptual framework, catalogue and analysis on the typology, characteristics and cost of services to be provided by the European Reference Networks and its Members. The last item on this month’s agenda is the contract that will be signed, before the end of the year, between the Commission and the contractor for systemizing an evaluation manual and toolkit intended to support proper assessments of ERN proposals. For further information on cross-border healthcare and ERNs, please visit the dedicated website.
The core strategy of the NEOMERO Project includes the combination of two clinical trials: Neomero1 (an open-label, randomised, multicenter, comparator-controlled study to evaluate the PK, efficacy and safety of meropenem as compared with standard antibiotic therapy in neonates and infants aged < 3 months treated in neonatal intensive care units (NICU) for late onset sepsis (LOS) defined as sepsis appearing after 72 hrs from birth) and NeoMero2 (an open label, multicenter, observational study to evaluate the PK and safety of meropenem in neonates and infants aged < 3 months with bacterial meningitis admitted to NICUs). As of December 27th, 2013, the trial status is the following: 166 patients have been randomised in NM1 study and 25 patients have been included in NM2 study.
CVBF 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 October 20th with the title "CVBF - Innovazione nella ricerca clinica pediatrica" (CVBF - Innovation in paediatric clinical research). http://issuu.com/comunicazionecvbf/docs/02_cvbf3/0