PARTNER 12: Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF)
CVBF is a consortium between the University of Pavia and the ‘Salvatore Maugeri’ Foundation, a Research Institute for Care Delivery appointed by the Italian Minister of Health. Its mission is to perform research and education in the pharmaceutical field integrating regulatory, epidemiological, economical and statistical expertise. Main activities: regulatory activities (orphan and paediatric drugs); new methodologies for clinical trials for small population and for new and innovative drugs (biotechnology, biological modifiers); train experts in pharmaceutical fields (scientific, regulatory and organisational knowledge); disseminating research findings intended to support policy and operational changes within the health care system. CVBF is involved in research projects funded by public and private systems at national and international level (Task Force for Drug Development for the Young – TEDDY, a FP6 Network of Excellence; EuOphan, an e-TEN market validation project.
Management structure
The management of the NeoMero project is closely connected to the scientific coordination and therefore the overall organisational structure and management procedures benefit from this synergy. Scientific coordination and project management are essentially built up around WP1 and WP9 and will be a responsibility of PENTA.
The management structure has been designed with the following components:
The management structure has been designed with the following components:
- Steering Committee (SC): An executive body comprising Work Package leaders, including the Scientific Co-ordinator, with decision powers on technical development, work plan updates, and effort and budget re-assignment within Work Packages.
- Scientific Co-ordination (SciC): A key role in charge of the global scientific leadership, quality assurance policy and assessment of the project.
- Project Management (PM): A management team set up by PENTA for daily management of the project.
- Ethical advisory board and Data Safety Monitoring Committee (DSMC): An ethical advisory board will be established to oversee the ethical and data protection issues which will also be included in the annual report to the Commission. The same body will also assist the Steering Committee for scientific and technical matters concerning data safety monitoring.
- Work Package Leaders (WPL): Leading participants of each work package.
- Activity Leaders (AL): Leading participants of each activity.