On 10-11 February 2020 EUCROF will organise the 5th European Conference on Clinical Research in Amsterdam. The primary objective of the Conference is to ensure that all attendees are brought fully up to date with the current key topics in Science, Technology and Regulations and how each of these can contribute to improving patients’ health. The Conference will be focused on “Science, Technology and Regulations Coming Together for Better Patients’ Health”. The Conference will provide the occasion to discuss the fast increase of technological solutions in clinical research, data capture a delivery field. The drug and medical device development, in fact, requires competences to cope with a continuously changing environment – always focussing on the ultimate goal: the benefit for the patient. To participate in the event, it is necessary to register by filling in the form at this link. More information about the event and the programme is available here.
The annual AICRO Conference will take place on 12 November 2019 in Milan at Assolombarda, Sala Auditorium Gio Ponti. The event will be focused on the theme “Digital revolution in health and "connection" with the future: a challenge for the involved professionals” but it will also be declined based on the evolution of the professional figures operating in this sector. The speakers involved will present their experiences in "talk show" mode and will be available for a fruitful exchange of views with the audience. AICRO is the Italian Association of Contract Research Organisation, founded in 2004 with the aim to ensure quality standards in the practice of clinical trials, promoting the use of GCP (Good Clinical Practice) and relevant regulations (GLP, GMP, etc.), as well as national and international guidelines, where applicable. The Organisation collaborates with other authorities and recognized associations in order to further develop clinical research, particularly taking into account the benefit for the patients. Every year AICRO organises an event dedicated to clinical research to address very topical issues on the evolution of management of clinical trials in Europe and Italy in particular. More information about the 6th Conference on Clinical Research are available at this link.
The next EUCROF Webinar on “Risk-based and Remote Monitoring” will be held on 23 July 2019 at 10.00. The webinar will be held by Dr. Goran Vesov, Quality Assurance and Training Director at OPTIMAPHARM, and Dr. Ana Stojkovic Country manager at OPTIMAPHARM and registrations are available at this link. With the increasing complexity of the clinical trials, a need has surfaced for emphasising critical vs less important aspects of clinical trial management. Analysis for the efficacy of the traditional approach to monitoring of clinical trials demonstrated an unfavourable ratio between efforts and effect. ICH GCP E6 R2 defines innovative approaches, which include Quality Risk Management, Quality-By-Design, prioritised resourcing and risk-based monitoring. This webinar will focus on risk-based monitoring as a principal measure for improving the quality and effect of the outcome of the clinical trials monitoring, whilst respecting resourcing needs. Other main topics will include remote and centralized monitoring and their role in the risk-based approach. For more information please visit the official EUCROF website.
The proposal Factory EVOLUTIO START UP” coordinated by CVBF, CNR and Bioindustry Park, has been granted to the “Estrazione dei Talenti (Talent Extraction)” programme, promoted by the Apulia Region. The "Factory EVOLUTIO START UP" will be aimed to support the evolution and consolidation of the individual business initiatives promoted in the framework of the Talent Extraction initiative, through specific pathways of mentoring and coaching focused on technological transfer and business development, initiatives to support the strategies definition, business models and business plans, thus helping the start-upper Teams to achieve a good level of prospective sustainability and to promote the possible transformation of "ideas of business” in real innovative companies. Factory EVOLUTIO START UP will include a pool of experts coming from CVBF, the University of Bari, Gianni Benzi Foundation, the Bioindustry Park (BIPCA) and the National Research Council (CNR) of Bari.
The activities of #wecare_ye project have been officially started! On 28-29 May 2019, the Advanced Programming Visit (APV) took place in Bari at the Paediatric Hospital “Giovanni XXIII”. The #wecare_ye project, coordinated by CVBF and funded under the European Erasmus + program, has the long-term goal to create four new Young Persons Advisory Groups (YPAGs) in Romania, Czech Republic, Greece and Belgium following the experience of KIDS Bari and KIDS Albania developed under the umbrella of the TEDDY Network, by fostering youth active participation (including young patients) in health promotion. To achieve this goal, a youth exchange will be organized in July 2018 with the group leaders responsible for the setting up of the group and the youngsters, aged 13-18 years, that have been selected by each organisation involved among those involved in their local activities (young patients, patients’ relatives, youngsters interested to health in general). The group leaders of each country participated in this preliminary meeting in May in order to organise the main activities of the youth exchange and define the meeting agenda. Also, the members of KIDS Bari participated in the APV and presented some examples of activities carried out in the last two years, providing a witness of the potentiality of the group for improving clinical research in paediatrics. For more information about YPAG, KIDS Bari and KIDS Albania please click here.
Consorzio per Valutazioni Biologiche e Farmacologiche is involved in the “conect4children” (c4c) project aimed to implement and test a collaborative network for European clinical trials for children. In the framework of the project, four no-profit clinical trials have selected and will be funded. CVBF will participate in two new no-profit paediatric studies and will be in charge of CRO-like activities. The first study cASPerCF (Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection) intends to provide a prospective validation and clinical evaluation of safety and efficacy of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and aspergillus infection. CVBF will be in charge of monitoring activities and data management. The second study MOI (Matrix-directed therapy in children with osteogenesis imperfecta) is aimed to establish the Optimal Biologic Dose (OBD) of losartan in 30 children aged 8-17 years with OI (Matrix-directed therapy in children with osteogenesis imperfecta) as well as to determine the changes in proxy efficacy outcomes of bone (mass, architecture and strength) and muscle (strength), and determine changes in quality of life using a validated disease-specific tool. CVBF will deal with the monitoring and archiving activities. For this reason, CVBF is hiring and has opened a call for new positions for experienced CRAs located all over Europe, to conduct monitoring activities in the context of these multinational paediatric studies. To apply click here.
In the framework of EPTRI (European Paediatric Translational Research Infrastructure), a project coordinated by Consorzio per Valutazioni Biologiche e Farmacologiche and funded within the H2020-INFRADEV-01-2017 programme, a call for application for the preparation of EPTRI feasibility studies has been launched. EPTRI arises from the need to find answers to the serious lack of medicines for children in EU and worldwide and is aimed to create the framework for a new Research Infrastructure (RI) intended to enhance technology-driven paediatric research in drug discovery and early development phases to be translated into clinical research and paediatric use of medicines. As EPTRI is a design study, the call for Feasibility studies is aimed to test the process, the scientific interest, the availability of requested services and facilities needed to conduct paediatric research in the areas of EPTRI competence. All the proposals will then be assessed by the Advisory Board A to verify if: the proposal meets EPTRI mission and abilities; the proposal is likely to be completed by the end of ID-EPTRI project; the scientific contents are valuable; services and facilities within EPTRI are available to perform the work. The call will remain open until the 15 July. More information about the project are available on the EPTRI official website.
On 13-16 June 2019, the 24th European Hematology Association Congress took place in Amsterdam and brought together more than 12000 haematology professionals from around the world. During the meeting, the preliminary results of the DEEP-2 study have been presented by the principal investigator of the study Prof. Antonis Kattamis, from the Department of Pediatrics, National and Kapodistriam University of Athens. DEEP-2 is a multicentre, randomized, non-inferiority trial comparing the efficacy of deferiprone (DFP) in paediatric patients affected by transfusion-dependent hemoglobinopathies. The trial is one of the studies foreseen within the framework of DEEP (DEferiprone Evaluation in Paediatrics), a 6-year European project funded by the European Union’s 7th Framework Programme for Research and Technological Development, coordinated by Consorzio per Valutazioni Biologiche e Farmacologiche and aimed to study the efficacy and safety of deferiprone (the first oral iron chelators developed in Europe) in children affected by β-thalaessemia major and other transfusion dependent haemoglobinopathies. DEEP-2 trial provided evidence to support the use of DFP in paediatric patients as presented at the European Hematology Association Congress, that was the occasion to share the last outcomes in terms of the diagnosis and management of patients with haematological disorders, as well as of the cutting edge basic, translational and clinical research. The extensive congress program included over 400 sessions of invited presentations, abstract presentations and sponsored sessions from EHA’s industry partners. If you want more information, have a look at the Congress report by clicking here.
16th May 2019. Presentation of the final Document of the Consultation on civic participation in healthcare system. The KIDS Bari contribution
The final event of the project "Consultation on civic participation in healthcare system", promoted by Cittadinanzattiva with the non-conditioning contribution of Novartis, was held on 16th May, 2019 in Rome at “Sala Igea – Treccani”. The consultation process took place on 30th and 31th January ,2019 at the Luiss EnLabs, involved 100 health stakeholders and resulted in the release of a final Document and presented during the final event in May. The result of this work was the sharing of a “Matrix for the quality of participatory practices” which, starting from the identification of risks and appropriate actions to minimize them, aims to become a useful tool for public institutions to shape their participatory practices in public health policies and ensure an effective involvement of citizens. Many experts worked on the drafting of the document, including representatives of institutions and health professionals, researchers, experts and citizens. Mariangela Lupo, Team Leader of KIDS Bari, the first Italian YPAG (Young Persons Advisory Group), and Antonio Di Pietro, one of the young members of KIDS Bari, were among the collaborators who reviewed and developed the document, providing useful insights for the analysis of participatory practices in healthcare system, such as the need to encourage and guarantee the continuous and adequate training of personnel. In this regard, the document highlighted and suggested the e-learning course "ICH-Good Clinical Practice (GCP)", promoted by Consorzio per Valutazioni Biologiche e Farmacologiche and designed to provide a guide for all the professionals involved in clinical research and trials clinicians. Likewise, patient’s involvement and in particular children engagement in the clinical process should be a fundamental practice, needed to maintain the trust of stakeholders and citizens. In this regard, the role of TEDDY European Network [...]
New positions are opening for experienced CRAs located all over Europe, to conduct monitoring activities in the context of two multinational paediatric studies. To apply click here.