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Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF)

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Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF) is a consortium between the University of Bari “Aldo Moro”, the Fondazione per la Ricerca Farmacologica Gianni Benzi (FGB), the European Network of Excellence for Paediatric Clinical Research (TEDDY) and Mediterranea Associazione per lo Sviluppo Locale (MEDITERRANEA). CVBF is a non-profit scientific research organisation with the mission to perform research and education in the pharmaceutical field integrating regulatory, clinical, epidemiological and economical expertise.

CVBF can count on the expertise and collaboration of scientists in the health field and paediatric clinical research experts working together to identify the most appropriate research tools that reflect the specificity of the paediatric population. CVBF is also particularly engaged in favoring awareness on the topics of paediatric research, to spread information on the rational use of paediatric medicines and to identify unmet medical needs in paediatrics.

CVBF has developed significant expertise in the field of the paediatric medicines development and paediatric clinical trials conduct as sponsor of independent trials and providing specific services related to clinical operations management, pharmacovigilance, data collection and analysis, quality control and drug management.

Main tasks in the Project:

CVBF is the ID-EPTRI coordinator, having a long lasting experience in the project coordination and will be also in charge of the organisation and technical design (model) of the research infrastructure, leading the work package 4. In particular, within the project CVBF will be involved in the following work packages (WPs):

WP1. As Coordinator, CVBF will assure the project success, continuously maintaining team awareness on progress against the work plan and any key emerging issues relevant to the project.

WP2. With the support of FGB and TEDDY as third parties, CVBF will be actively involved in the project governance and sustainability with the aim to integrate the new infrastructure into the European landscape.

WP3. CVBF will have a key role in the first phase of the project that foresees the development of a Context Analysis. In particular, CVBF with the support of its third parties, will be in charge of:

  • setting up scientific and clinical reference groups to perform analyses on the various type of needs expressed by the paediatric research communities
  • providing the technical support to develop an online questionnaire to survey the academic and research units to be included in the research infrastructure.

WP4.  CVBF will lead this WP and, with the support of FGB will collaborate with the other partners to define organisation and technical design (model) of the infrastructure that will be in line with the outcomes of the context analysis. Moreover, it will be in charge of the design of an Information Technology (IT) platform and the integrated service to allow knowledge translation Design.

WP5-WP6-WP7-WP8-WP9. CVBF with the support of its third parties, will collaborate in the design of the five thematic platforms. The University of Bari will be involved in the “Formulation Science” thematic platform, the TEDDY Network will collaborate within the thematic platform to relate work that underpins medicines development to paediatric clinical studies.

WP10. With the support of its third party FGB, CVBF will collaborate to provide advice to all the other WPs on ethical aspects.

WP11. In collaboration with its third party TEDDY, CVBF will play a key role in the Communication, Networking and Patients involvement activities.

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