22nd February 2023

Newsletter February 2023

Clinical research is undergoing a moment of great change due to the increasingly use of digital technologies, artificial intelligence, and decentralized systems to meet the needs of sustainability, greater active patient involvement, and more efficient execution of study procedures, to make trials on innovative products more feasible, and to foster efficient real-world data collection.

CVBF is always up-to-date with these new trends and ready to tackle every challenge the future has in store.

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 recognition of GCP training among all the trial sponsors.

For all our Newsletter subscribers the course will be freely accessible signing up at www.gcptraining.cvbf.net. Feel free to share this unique opportunity within your network: tell them to visit our website, subscribe to our newsletter (banner at the bottom of the homepage) and then sign up to the course! For any technical issue don’t hesitate to contact us at [email protected].


CVBF participates in the Smarter Programme For Technological Innovation

Thanks to the close collaboration with Aldo Moro University of Bari, Exprivia spa and Hero srl, and following the agreement signed with the Italian Ministry of University and Research in the context of the call “Innovative Virtual and Augmented Reality applications for people with an autism spectrum condition (ASC)”, we are about to start a research and development project aimed at improving the living conditions of people with autism spectrum disorders.


CVBF is about to start a project to speed up and facilitate the diagnosis of celiac disease

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 Ministry of Health through, aiming at facilitating the diagnosis of celiac disease.

CVBF Scientific Director is a member of the Exploitation Board of the AMELIE project

CVBF Scientific Director Giovanni Migliaccio took part at the 2023 AMELIE (Anchored Muscle cELls for IncontinencE) General Assembly meeting that was held in Lisbon on the 2nd of February, where work package leads shared their updates on the ongoing activities related to the study. Within this important event, he was appointed as a member of the Exploitation Board as well as a reviewer of the clinical study protocol.
AMELIE is a 5-year collaborative research project funded by the European Union Framework Programme (Horizon 2020) involving 13 organisations across 9 countries and it comprises a highly interdisciplinary consortium of experts who are proposing a novel regenerative intervention using autologous skeletal muscle derived cells (ASMDC) to restore the function of the sphincter muscle.

CVBF speakers on different aspects of the management of clinical trials 

We are proud to share with you two activities in which our specialists have participated as speakers.
In the webinar organized by the Italian Association of CROs (AICRO), with the topic of EU Regulations in Clinical Trials held on 17 November 2022, Cristina Manfredi, our Senior Regulatory Officer, held a speech about the state of the art of submissions in CTIS and the involvement of Italy as a Member State in this new submission process.
Mariagrazia Felisi, our Head of Quality Assurance, and Ana Dilo, our Clinical Project Manager, took part as speakers in the Audit & Inspection Readiness Course which was organized by conect4children (c4c) on 16 and 17 January 2023. The course was focused on how an inspection (or an audit) should be prepared and conducted by the staff of a Clinical Trial site.


CVBF Scientific Advisor is guest editor of the Frontiers in Paediatric


Adriana Ceci, our Scientific Advisor, has been invited as guest editor of the special issue dedicated by the Frontiers in Paediatrics journal to the topic “Supporting the Pediatric Drug Development: From Basic Research to Clinical Studies and Technological Advancements”. This special issue is supported by EPTRI, the European Paediatric Translational Research Infrastructure.

The aim of this Research Topic is to contribute to the international progress in paediatric research by supporting and facilitating the publication of high-quality studies on a variety of aspects of drug development that can have an impact on children’s therapeutics and health.

CVBF supports the Rare Diseases Day


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 Fondazione per la Ricerca Farmacologica Gianni Benzi on February 23 at the IRCCS Istituto Tumori “Giovanni Paolo II” in Bari. Rare cancers are a heterogeneous group of more than 200 types of neoplasms, often associated with rare non-oncologic diseases caused by genetic alterations.


The TEDDY Network is organizing a meeting dedicated to rare diseases, which will be held in hybrid mode on Friday 24 February. Manika Kreka, Medical Director of the Albanian CVBF’s branch, will talk about rare diseases and particularly rare haemoglobinopathies with the TEDDY Kids and the Young Persons Advisory Group from Athens, Bari and Tirana.




The paper on the management of biosample in paediatrics research is finally out 

Authors from CVBF, the Fondazione per la Ricerca Farmacologica “Gianni Benzi”, and the European Clinical Research Infrastructure Network, published an article on the Clinical and Translational Science Journal to promote and implement specific procedures and guidelines on the management of biological specimens while performing paediatric research.

In this paper, our researchers presented an easy-to-use tool, developed as part of the PedCRIN project, to guide investigators, sponsors, and research stakeholders involved in paediatric clinical trials, in the management of these samples and associated data in compliance with applicable European standards. CVBF has been one of the partners in the PedCRIN project, and our CEO, Donato Bonifazi, acted as Work Package 3 “Tools for paediatric trials” Leader.

 Regulatory News


Use of Clinical Trials Information System becomes mandatory for new clinical trial applications in the EU

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). The Clinical Trials Regulation (CTR) foresees a transition period. By 31 January 2025, all ongoing trials that were approved under the Clinical Trials Directive will be governed by the new Regulation and will have to be transitioned to CTIS.


Implementation in the Italian legal system of the European Regulation 536/2014 on clinical trials

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. Another important measure long awaited and decisive in terms of administrative simplification, is the decree, adopted by the Minister of Health in agreement with the Minister of Economy and Finance, determining the single fee for clinical trials.

CVBF Regulatory Team is willing to assist you as Sponsor of CTs in the EU. Please contact us at [email protected].

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About the Author: Flogert Dollani


By Published On: February 22nd, 2023Categories: Newsletter0 Comments