On July, 14th 2015, the Scientific Committee of CVBF has been officially appointed and composed by the following representatives: Adriana Ceci, Annagrazia Altavilla, Enrico Bosone, Pietro Folino, Cosimo Altomare, Maria Mellado, Viveca Odlind.

According to art. 20 of the Statute of CVBF, the Scientific Committee operates with the aim to provide an operative contribution to the annual planning and implementation of CVBF scientific activities. It will participate in the proposal of new initiatives, the development or revision of documents and research papers, the preparation of research projects of common interest that are competitive both at national and international level, as well as the planning and organisation of events.

The meeting was divided in two sessions, with the first one dedicated to the presentation of the Consortium and its members: University of Bari “Aldo Moro” (UniBA), Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus (FGB), the Italian Group for Pharmacoeconomic Studies (GISF), PHArmaceutical Research Management srl (PHARM) and Bioikòs Farma srl (BIOIKOS).

The second session was aimed to present an overview of CVBF scientific activities, which can be classified in the following five main areas:

1. Paediatric medicines and orphan drugs
2. Ethical aspects of clinical trials
3. Innovative models for clinical trials
4. Post-marketing studies, registries and health technology assessment
5. Training activities.

With reference to Paediatric medicines and orphan drugs, the databases managed by CVBF were presented and in particular:

• Drugs for children: European Paediatric Medicines Database (EPMD), a database containing information on paediatric drugs authorised by the European Medicine Agency (EMA) under the centralised procedure, with the aim to create a harmonised, integrated and reliable European source of information;
• Drugs for rare diseases: EuOrphan, a free and regularly updated database containing information from official sources on drugs available on the market or in development in Europe and in US for rare diseases, including “orphan drugs” (ODs) designated and marketed by EMA and the Food and Drug Administration (FDA) respectively. A new database version will be available on a restructured website.

Regarding the ethical aspects of clinical trials, V. Giannuzzi showed the CVBF long lasting experience in the ethical and regulatory framework, starting from the work performed in TEDDY project on ethical aspects and procedures to perform paediatric research. She pointed out that CVBF/FGB also participated in the international discussion and public consultation on the revision of Directive 2001/20/EC and on the proposal for the new EU Regulation on Clinical Trials.

With reference to the area “Innovative models for clinical trials”, P. Baiardi highlighted that CVBF has developed research activities to develop and improve scientifically, clinically and logistically plausible alternatives to the classical designs for paediatric clinical trials. Such results have been included in training courses and peer-reviewed publications and have been applied in paediatric clinical trials.

With reference to post-marketing studies, registries and health technology assessment, many studies have been presented. It is particularly important to mention the HTA-Thal project, in which an Italian Multiregional Thalassaemia Registry has been developed with the aim to collect epidemiological and clinical data on beta-thalassaemia patients referring to Italian centres.

The last part of the session was focused on the high-level training activities (residential and e-learning courses), in which CVBF is particularly involved and devoted to consolidate the existing knowledge, taking into account the current European strategies in the Regulatory field.

2015. Bonifazi, CEO of the Consortium, explained that CVBF is involved in the design and execution of Continuing Medical Education (CME) programmes and is accredited by the Italian Committee for Continuing Medical Education (Age.Na.S.) as a Provider of Italian ECM credits, and included in the list of providers authorised to carry out residential and e-learning courses. The main residential training activities are the annual Foresight Training Courses, short intensive face-to-face courses on regulatory sciences). To date, seven Foresight Training Courses have been organised and the eighth editions is planned to be held in Warsaw in September 2015.

The meeting concluded with an overview of actions planned that have been discussed by the new established Scientific Committee.

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