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CVBF answered to the Public Consultation: Pharmaceuticals – safe and affordable medicines (new EU strategy)

The European Commission is launching a new strategy to improve and accelerate patients’ access to safe and affordable medicines and to support innovation in the EU pharmaceutical industry, addressing mainly: the life cycle of medicines from R&D to authorisation and patient access how to put scientific and technological advances into practice how to fill market gaps (e.g. new antimicrobials) lessons learnt from COVID-19 on how to better prepare for future pandemics Consorzio per Valutazioni Biologiche e Farmacologiche as coordinator of the European Paediatric Translational Research Infrastructure (EPTRI) provided its comments underlining the necessity to stress new adequate health policies and actions promoting the development and the access to safe and efficacious medicines specific for children. In fact, specific efforts should be made to guarantee innovative and high-quality health care, available for all citizens with particular attention for the groups, e.g. paediatric and rare diseases populations, often excluded by last advancements in the health field. It is possible to read the complete document at this link. It is possible to participate to the Public Consultation until 15 September 2020 by filling in the online questionnaire available at this link.

2020-08-17T15:39:18+00:00 07/08/2020|Categories: News & Events|

CVBF is involved with the University of Pittsburgh in developing two vaccines for the coronavirus disease

We are glad to inform you that Consorzio per Valutazioni Biologiche e Farmacologiche will provide its contribution in the fight against COVID-19 emergency. It was recently been entrusted by UPMC - University of Pittsburgh Medical Center with the two studies on COVID-19 which aim to test two  vaccines in the form of a patch (protein subunit) and in intranasal spray (Adenovirus), both are phase I / II studies on healthy volunteers. In particular, the first study is a Phase I/ II Adaptive Clinical Trial to assess safety, tolerability and immunogenicity of PittCoVacc, a Microneedle Array Delivered SARS CoV- 2 Subunit Vaccine, in Healthy Adult Volunteers. The second is an open-label randomized Phase I/II clinical trial of Ad5.SARS-CoV-2-S1. CVBF will be involved in the whole study process, dealing with protocol finalisation, IB and IMPD preparation, submission, study management and monitoring, pharmacovigilance, data management and statistics.

2020-08-17T14:21:38+00:00 07/08/2020|Categories: News & Events|

COVID-19: EMA sets up infrastructure for real-world monitoring of treatments and vaccines

EMA has now set up an infrastructure to support the monitoring of the efficacy and safety of COVID-19 treatments and vaccines when used in day-to-day clinical practice. This is underpinned by three contracts for observational research that EMA has signed with academic and private partners over recent months, to be ready to effectively monitor medicines and vaccines in the real world as soon as they are authorised, and support the safe and effective use of COVID-19 vaccines and medicines. The three projects are: with Utrecht University and the University Medical Center Utrecht as coordinators of the CONSIGN project (‘COVID-19 infectiOn aNd medicineS In preGNancy’) with IQVIA company with a project to build a framework for the conduct of multicentre cohort studies on the use of medicines in COVID-19 patients. ACCESS project (‘vACcine Covid-19 monitoring readinESS’)commissioned by EMA for preparatory research into data sources and methods that can be used to monitor the safety, effectiveness and coverage of COVID-19 vaccines in clinical practice, once authorised. The outcome of the various projects conducted on observational research will be fed into the work of EMA’s COVID-19 pandemic Task Force (COVID-ETF) and EMA’s scientific committees, to ensure that this evidence is translated into scientific opinions on the optimal use of the medicines and vaccines concerned. More information is available here.

2020-08-17T14:18:09+00:00 07/08/2020|Categories: News & Events|

CVBF is involved in the multinational cASPerCF clinical trial

In the framework the c4c IMI2 funded project (pan European paediatric clinical trials network) cASPerCF study will be carried out. The study is being led and coordinated by the MRC Centre for Medical Mycology at the University of Exeter, United Kingdom, in collaboration with the Children’s Hospital Bambino Gesù in Rome, Italy, which acts as the sponsor of the study. Other institutes and organisations involved in the study are the Radboud University Medical Centre, Nijmegen, the Netherlands, the European Cystic Fibrosis Society, and more than 30 clinical sites located in 10 countries all over Europe. The study will assess the dose of posaconazole in children and adolescents with Cystic Fibrosis and Aspergillus infection. Children and young people aged 8-17 years old with Cystic Fibrosis across Europe will be recruited into this study. cASPerCF plans to open the trial in late 2020. In this study, CVBF is responsible for Sites Assessment, Data Management, Study Monitoring, Trial Master File Preparation and Maintenance.

2020-08-17T15:40:51+00:00 07/08/2020|Categories: News & Events|

CVBF has just overcome a GCP audit by AIFA, the Italian Medicines Agency

Since 2002 CVBF has been acting as Sponsor and Clinical Research Organisation (CRO) involved in clinical trial execution and it is currently ready to provide its expertise in clinical trials at national and international level, with a specific attention to the field of paediatric and rare diseases. Another important goal has been just reached by CVBF, successfully overcoming 3 days of Good Clinical Practice (GCP) Audit by the Italian Medicines Agency (AIFA). The activities cover all phases of clinical trials Phase I-IV by providing specific services related to clinical trial management, regulatory and ethics, clinical sites selection and contracting, clinical operations and drug management, data management and monitoring, statistical analysis and medical reporting, pharmacovigilance. Many activities are conducted in the context of EU funded projects and are focused on the development and application of innovative methodologies in clinical trials for small populations (e.g., rare diseases, paediatrics), as well as the management of interventional, non-interventional, health technology assessment and pharmacoeconomic studies, as well as disease registries. Here you can find more about CVBF Clinical Research area.

2020-08-17T15:42:33+00:00 07/08/2020|Categories: News & Events|

Public Consultation on Good Lay Summary Practice and the Roadmap Initiative

The European Medicines Agency (EMA) released an Expert Group Recommendation on the content of Lay Summaries of clinical study results from commercial and non-commercial sponsors. The upcoming Clinical Trial Regulation, in fact, requires the development and dissemination of Lay Summaries of clinical study results from commercial and non-commercial sponsors. However, there is no guidance for all types of sponsors on how best to handle the development process of Lay Summaries and how best to ensure reliable dissemination so that the ultimate goals can be achieved: increase of clinical research transparency, patients’ and public’s understanding of clinical research as well as feedback to study participants about the results of their study. For this reason a group of 60 participants from EU and US pharmaceutical companies, CROs, academic institutions, patient organisations, and not-for-profit organisations under the leadership of The European Forum for Good Clinical Practice (EFGCP) and The European Federation of Pharmaceutical Industries and Associations (EFPIA) has created the “Roadmap Initiative to Good Lay Summary Practices” with the aim to develop a pragmatic, broadly accepted framework for Lay Summary development, content and dissemination. For this purpose, 6 different Task Forces were created: Task Force 1: Principles and processes of Lay Summary implementation beyond existing guidances Task Force 2: Competencies required for development and translation of Lay Summaries Task Force 3: Lay Summary dissemination within and beyond the EMA Portal and EUDAMED Task Force 4: The issues of Lay Summary creation, translation and dissemination funding, particularly for academia and SMEs Task Force 5: Suitable technology to reach patients, the health-interested public and healthcare professionals Task Force 6: Paediatric Trials Lay Summaries Consorzio per Valutazioni Biologiche e Farmacologiche took part in the group, especially contributing to the Task Force [...]

2020-08-17T15:44:06+00:00 07/08/2020|Categories: News & Events|

EPTRI Stakeholders Roundtable was held on July: what are the future strategies of the paediatric research?

On 9 July 2020 the EPTRI (European Paediatric Translational Research Infrastructure) Stakeholders Roundtable was held online. The virtual meeting provided the possibility to discuss about the future strategies of collaboration with other biomedical research infrastructures and European initiatives and networks relevant for paediatric research. The meeting was very successful and provided a further occasion to continue joining the efforts and strengthening the collaboration with the goal to accelerate paediatric medicines development. The roundtable was organised as a discussion around some key documents developed within EPTRI project as the Conceptual Design Report of EPTRI including its business model, governance model and service catalogue developed during the Design Phase, as well as an outreach plan to link EPTRI to other initiatives of interest in the field of research to promote children’s health. Stakeholders from EU institutions, governments, European RIs and projects, agencies, networks, ERNs, patients’ associations, charities, research organisations and also partners from non-EU countries have been invited to join. The recording of the event are available on the EPTRI YouTube channel and the EPTRI website.

2020-08-17T15:46:17+00:00 07/08/2020|Categories: News & Events|

Paediatric Devices survey. Your help is needed! Share your experiences of using devices to take medicines

The European Paediatric Formulation Initiative (EuPFI) works to improve the preparation of better and safer medicines for children. One area they are interested in is the “gadgets” or devices (e.g. measuring spoons, dosing cups, inhalers) that are used to help patients take their medicines. It is important that these devices are used properly to make sure the correct dose of medicine is taken. The EuPFI devices workstream have designed a short questionnaire to understand what devices you or your child use and how easy they are to handle, to help to find ways of making the devices more user friendly. EPTRI (European Paediatric Translational Research Infrastructure) promoted the review of the questions by the young members of Albanian, Italian and Spanish YPAGs (Young Persons Advisory Groups) and supports the dissemination of the survey. The survey is addressed to boys and girls between 10 to 18 years of age and their parents. It will take approximately 10-15 minutes to be completed. The survey is available in the following languages: English, Italian, Albanian and Spanish: Albanian: Paediatric Devices Survey KIDS Albania   Italian: Paediatric Devices Survey KIDS Bari Spanish: Paediatric Devices Survey KIDS Barcelona English: Paediatric Devices Survey English  

2020-08-20T12:25:30+00:00 19/06/2020|Categories: News & Events|

SAVE THE DATE – Webinar AICRO: The concept of “vigilance” in clinical studies widens the boundaries: from the experience on the drug to the medical device

On June 25, 2020, from 11.00 to 13.00, the AICRO training webinar will be held. The webinar is entitled: The concept of "vigilance" in clinical studies broadens the boundaries: from experience on the drug to the medical device. The regulatory background, language and methods of action: compared experiences. It will be an interactive seminar, although in webinar mode, where the requirements of pharmacovigilance in the context of clinical trials will be addressed, to then discuss the imminent need to adapt the "surveillance" activity also to the medical devices field. The speakers will refer to the current legislation and share direct experiences with the participants, offering a multifaceted panorama for different actors: CROs, Sponsors, Clinical Trial Centers. Mariagrazia Felisi, Clinical Research Director at Consorzio per Valutazioni Biologiche e Farmacologiche, will be among the speakers of the webinar and will provide an overview of regulatory landscape on the drug, describing the role of the User in Eudravigilance and the delegation process. More information on registration modalities and the agenda of the event is available at this link.

2020-06-17T16:30:07+00:00 17/06/2020|Categories: News & Events|

Clinical Trials Digital Week

On 2020 June 1-4, the event “Clinical Trial Digital Week” took place as a global 4-day series of live educational webcasts and downloadable resources providing the latest insights for operational challenges and responding to a pandemic, partnerships, outsourcing and operations, technology in clinical trials, and clinical innovation. This edition foresaw the participation of Mariangela Lupo, Communication and Patient Advocacy Manager at TEDDY European Network of Excellence for Paediatric Research, member of CVBF. She held the webinar entitled “The Patient Centricity Effect – How It benefits Patients, Sites and Sponsors – Practical Cases From Paediatric Studies”. The webinar provided practical examples on how to involve children in clinical trials. A child-friendly approach is necessary not only in the daily clinical practice, but throughout the research and development process, from setting research priorities, involvement in research design and planning, research conduct through to dissemination and communicating research findings. The recording of the webinar is available at this link.

2020-06-17T15:59:58+00:00 17/06/2020|Categories: News & Events|