The Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF) is a not for profit organisation with the mission to provide scientific, economic and regulatory consultancy for innovation in the health sector at European level. The main fields of interest are life sciences and biotechnologies, drug development for small populations (paediatric – rare diseases), research management, clinical trial methodology, monitoring and statistics, ethics and pharmacovigilance.
CVBF has longstanding experience in the field of rare diseases and paediatric research where acts as certified CRO by providing services related to clinical trial management. It is also a member of the Italian Association of CROs (AICRO) and of several scientific networks promoting clinical trials. CVBF has developed significant expertise as Coordinator of several international projects, including FP6 and FP7 funded grants such as TEDDY (European Network of Excellence for Paediatric Clinical Research and DEEP (DEferiprone Evaluation in Paediatrics).
CVBF is and has been also Partner in other European (FP7 and DG Sanco) projects: GRiP (Global Research in Paediatrics), NeoMero (European multicenter network to evaluate pharmacokinetics, safety and efficacy of Meropenem in neonatal sepsis and meningitis), NeoVanc (Treatment of late onset bacterial sepsis caused by Vancomycin susceptible bacteria in neonates and infants aged under three months), RESPECT (Relating Expectations and Needs to the Participation and Empowerment of Children in Clinical Trials), ARPEC (Antibiotic resistance and prescribing in European Children). CVBF is certified ISO 9001:2008, by Bureau Veritas.
CVBF is the Coordinator of the GAPP Project, responsible of the Project Management activities embedded in WP1. Of course it is also involved in all the other Work Packages with relevant roles. CVBF will guarantee that the project plan is completed in due time with the contribution of all the participating Beneficiaries and with the highest quality standards.
Ilaria Bergonzi, expert in project management and financial reporting, is involved in the Project Management Team.
Adriana Ceci, MD, PhD, Coordinator of CVBF Scientific Committee, President of Fondazione per la Ricerca Farmacologica ‘GianniBenzi’ Onlus, past PDCO member, expert for the paediatric area of the Italian Minister of Health, AIFA (Italian Regulatory Agency) and EMA. Prof Ceci is the scientific coordinator of the FP7 DEEP project and of the network TEDDY. She is referee of several international journals and author of 130 indexed publications mainly dealing with orphan drugs, paediatrics, regulatory issues.
Susanna Cotecchia, MD, PhD, experienced pharmacologist and Professor of Pharmacology at the Faculty of Biotechnological Sciences, University of Bari.
Mariagrazia Felisi PhD, degree in Life Sciences, PhD in Clinical Pharmacology and Master in Pharmacovigilance. Qualified Person for Pharmacovigilance and Quality Assurance at the CVBF.
Bonka Georgieva, Business Economics degree. Experienced in the management and the financial reporting of EC research projects.
Rachele Giuliani, graduated in Medicinal and Pharmaceutical Chemistry, certified Pharmacist is specialist in Clinical and Hospital Pharmacy. She has experience in Pharmacoepidemiology, Clinical trial Management and Pharmacovigilance. She is one of the official member of the HTA local Commission – Department for Health Policies of the Italian Region of Apulia. She is Coordinator of Drug Management Area at CVBF.
Virna Lomonaco, is a Project Manager with experience in the management of international projects and partnerships. She is currently WP1 Leader and coordinates the Project Management Team.
Cristina Manfredi, BSc (Hons), MA. Researcher and Pharmacovigilance Deputy at CVBF, she has experience in both project management and pharmacovigilance/regulatory affairs. Member of the project management team of the FP6 TEDDY project, she is currently involved in the research and regulatory activities of GRiP, NeoMero and NeoVanc projects, and in the project management of the DEEP project.
Laura Mangiarini, PhD in Advanced Biotechnologies and Master in Regulatory Affairs. She coordinated early and late drug discovery programs in an international pharmaceutical company. Currently CVBF representative in the Project Scientific Committee and scientific coordinator for the GAPP Project, WP3 Leader and former WP1 Leader.
Joana Millo is a Medical Oncologist and Clinical Research Associate, with experience in clinical trials in the field of Oncology. She recently have been accepted as a board member of Albanian Medico-Oncology Association and participated to most important investigator meetings worldwide.
Rosetta Padula is a chemist specialised as clinical research assistant (CRA) monitoring multicentre clinical trials.
Monia Romdhane Rodriguez is an expert Clinical Project Manager and Clinical Research Associate, with experience in medical monitoring on several therapeutic area such as Pediatric Heamatology, Endocrinology, Oncology, Ophtalmology, Cardiology.
Bianca Tempesta, PhD in Pharmacology and Toxicology, Drug and Technical Operations Manager for the FP7 Project DEEP, she will support the Drug Management activities in the GAPP Project.