Donato Bonifazi, our CEO, will attend as a speaker, the conference "La ricerca clinica profit e no profit su farmaci e device: Come massimizzare il beneficio per i pazienti?" that will be held on April 21st at the Aula Magna of the Monzino Cardiology Center IRCCS. This conference aims to underline the importance of clinical [...]
This 28 February is Rare Diseases Day (RDD), an opportunity to celebrate people living with rare diseases and to raise awareness of these disorders. Donato Bonifazi, our CEO, will attend, as a speaker, the convention Rare Cancers: Challenges and Opportunities, organized by the the Fondazione per la Ricerca Farmacologica Gianni Benzi on February 23, at [...]
CVBF collaborated with its member Fondazione per la Ricerca Farmacologica “Gianni Benzi” and the European Clinical Research Infrastructure Network (ECRIN) on an article published on the Clinical and Translational Science Journal, entitled "PedCRIN tool for the biosamples management in paediatric clinical trials". This research paper regards the need to develop and implement specific procedures and [...]
CVBF’s mission to perform education in clinical expertise comes to life with an online on-demand course on Good Clinical Practice. Having been recognized by TransCelerate as a training provider meeting standards criteria, CVBF offers all clinical research professionals the opportunity to be guided to the International ICH-GCP guidelines and its main principles by enabling reciprocal [...]
According to the European Medicines Agency (EMA), from 31 January 2023, all initial clinical trial applications in the European Union (EU) must be submitted via the Clinical Trials Information System (CTIS). Following a one-year transition, CTIS is now the single-entry point for sponsors and regulators of clinical trials for the submission and assessment of clinical [...]
The Italian Minister of Health has signed the four decrees on Ethics Committees, thus taking a decisive step towards the full implementation in the Italian legal system of the European Regulation 536/2014 on clinical trials. By Decree of the Minister of Health on January 26, 2023, with prior agreement in the State-Regions Conference, the number [...]
The consortium consisting of IRCCS Materno Infantile “Burlo Garofolo” (Project Leader), Azienda Ospedaliera Universitaria Federico II, Azienda ULSS2 Marca Trevigiana and Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF) has won a project founded by the Italian Ministery of Health through, aiming at facilitating the diagnosis of celiac disease. The project aims to validate a new [...]
In order to improve the user experience of the International Clinical Trials Registry Platform (ICTRP) search portal, the World Health Organization (WHO) is seeking input from current and potential users of the portal. The survey is anonymous and will take you approximately 10-15 minutes to complete. The survey is available here and the deadline has [...]
This recent article is part of Nature Outlook: Children‘s health and focuses on the lack of medicines approved for paediatric use. According to the article, “although the number of trials in kids has increased over the years, lack of data is still delaying paediatric labelling of drugs and leaving physicians with little information about whether [...]
EMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Hemgenix (etranacogene dezaparvovec), the the first gene therapy for the treatment of severe and moderately severe haemophilia B in adults who do not have factor IX inhibitors (auto-antibodies produced by the immune system which make factor IX medicines less effective). Haemophilia [...]
