Ho conseguito la laurea in Matematica e il Dottorato in Matematica e Statistica presso l’Università degli Studi di Pavia. Ho lavorato come Data Manager in ambito ospedaliero e in seguito come biostatistica presso l’Università di Milano occupandomi in particolare di analisi statistiche su biomarcatori prognostici in pazienti oncologici e di gestione di database clinici.
In CVBF ricopro il ruolo di biostatistica e collaboro con l’area del data management e della ricerca clinica.
Chief Executive Officer
Donato Bonifazi (MEcon), is an economist specialised in European Project Management and a certified Project Manager (CEPAS n. 9/2016). He is Trial Leader of two EU-funded Projects (DEferiprone Evaluation in Paediatrics and GAbapentin for Paediatric Pain, both funded within the FP7-Health), each involving more than 20 clinical centers from all over Europe and some Mediterranean countries.
He is President of AICRO, the Association of Italian Contract Research Organisations and member of the Paediatric Working Group of the EUCROF (European Clinical Research Organizations Federation). He is also member of the Working Group “Clinical Trial Preparedness” at the Enpr-EMA (the European Network of Paediatric Research at the European Medicines Agency) and coordinator of the TEDDY – European Network of Excellence for Paediatric Clinical Research, an independent Research Network (category 1 network member of Enpr-EMA), composed by 50 partners from 20 EU and non-EU countries aimed at facilitating the performance of good quality paediatric studies and research.
Donato Bonifazi is Project coordinator of EPTRI (European Paediatric Translational Research Infrastructure – GA 777554, INFRADEV-1-2017) aimed to create the framework for a new Research Infrastructure (RI) intended to enhance technology-driven paediatric research in drug discovery and early development phases to be translated into clinical research and paediatric use of medicines. He is also involved in the PedCRIN (Paediatric Clinical Research Infrastructure Network – GA 731046, INFRADEV-3-2016) project as WP3 Leader, dedicated to the development of tools to facilitate paediatric clinical trials.
Elisa is Pavia’s Office Manager. She in charge of managing human resources, internal communication and material resources of CVBF offices based in Pavia. Since 2016, she is also a Trial Archivist, collecting and storing all the documentation related to clinical studies of which CVBF either is the Sponsor or acts as CRO.
Master of Fine Arts Degree in Set and Costume Design. Expert in communication with paediatric patients and experienced in the preparation of informative packages and assent forms in several European projects (DEEP, GAPP, TEDDY).
She is responsible for Communication Area in CVBF (Consorzio per Valutazioni Biologiche e Farmacologiche). She’s team leader for the KIDS Bari, the first Young Persons Advisory Group in Italy.
Past-President and Board Member of Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus, Adriana Ceci had her academic carrier at the Aldo Moro University of Bari as researcher and PhD in Paediatrics and PhD in Clinical and Laboratory Haematology; she has been also lectured in many academic courses in the field of Paediatric and Regulatory Sciences.
She is Chair of scientific Committees in Paediatric Networks (INCIIPIT, the Italian Network of paediatric research and c4c – the pan-european paediatric clinical trial Network). Is Board member and funder member of TEDDY (Task-force in Europe for Drug Development for the Young–EU FP6) still running as Network of excellence for paediatric Research, participant in many research projects at national and international level. She is also Scientific Counselor of the Thalassemia Foundation ‘L. Giambrone’ Board and involved in international projects on Thalassemia and other haemoglobinopathies.
Past member of the Paediatric Committee at the European Medicine Agency (EMA) and of the Italian Ministry of Health – Commissione Unica del Farmaco, she also served as member of the “Commissione Nazionale del Sangue”, “Commissione per la Sperimentazione Clinica” at the Minister of Health, and other ministry technical commissions. She was also member of the CONI Antidoping Committee and of the Commissione Farmaco e Bambino appointed to Agenzia Italiana del Farmaco (AIFA).
Former member and Vice-President of the Commissione Sanità of the Italian Parliement and also member of the European Parliament where she founded the EU Parliamentary Inter -Group on Health that she coordinated for 5 years.
She is referee of several international journals and author of more than 140 indexed publications mainly dealing with orphan and paediatric medicines, blood disease, thalassemia, paediatrics, regulatory issues.
Clinical Research Associate
Ornela Cullufe is the Office Manager of Consorzio per Valutazioni Biologiche e Farmacologiche – Dege e shoqerise se huaj, Albanian Branch Office. She is involved in the Development and Networking activities and also in Regulatory and Pharmacovigilance area. She has been part of monitoring activities in the multicentric clinical study DEferiprone Evaluation in Paediatrics. She is one of the Team Leaders of the first YPAG (Young People Advisory Group) in Albania named KIDS Albania part of iCAN (International Children’s Advisory Network). She obtained her master’s degree in Pharmacy in 2014 from University of Medicine in Tirana (Albania). Prior joining CVBF, Ornela worked as pharmacist with extensive background in patient care, pharmacology, communication and implementation of health care programs.
Giusi Di Leo
Administrative Area Staff
Giusi Di Leo
Degree in Political Sciences, political-administrative address. Long-term experience in company-administrative secretariat and in the reporting of financed regional, European and national projects. From April 2012 she is Administrative Assistant for the CVBF.
Clinical Project Manager
Holds a Master degree in Pharmacy from University of Medicine Tirana (Albania) and a Master of Advanced Studies in Toxicology from University of Geneva (Switzerland). Previously worked as a pharmacist and the last role was Regulatory affairs & Pharmacovigilance responsible in a pharmaceutical company. Role in CVBF: Clinical trial assistant.
Clinical Research Director & Quality Assurance Head
Degree in Life Science, she received her PhD in clinical pharmacology from the University of Bari and her Master degree in Pharmacovigilance from the University of Florence. Qualified Person for PharmacoVigilance (QPPV) registered in EUDRAVIGILANCE, she is currently Projects Director at Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF). She is in charge of Pharmacovigilance and Quality Assurance in several paediatric clinical trials. She is lecturer of the Master in Regulatory Affairs of the University of Pavia and she also holds lectures in numerous national and international courses in her fields of expertise.
Maria Paola Felisi
Quality Management System Representative
Maria Paola Felisi
Technical diploma (commerce field). Administration and financial reporting in funded projects, Clinical Trial Assistance and trial documentation archiving with experience in Quality Assurance, ISO System, and data entry.
Paola Gandini is graduated in Biology and she has attended a master in Regulatory Disciplines. She currently covers the role of Data Manager at CVBF and she is involved in several multinational studies in the field of pediatric and rare diseases. Main activities: CRF designing, data cleaning and data reporting. Moreover, she interfaces day-by-day with clinical sites for any issue related to data management.
Bonka Georgieva is a WP2 internal reference person within the H2020 ID-EPTRI Project. She graduated from the University of Veliko Turnovo 'St. Cyril and St. Methodius' with master degree in 'Cooperative Management'. She participated in one-year Erasmus-programme scholarship with technical-economic address at the University for Foreigners Perugia. After graduation, she moved to Italy where she had different work experiences in international relations between Italy and Bulgaria as well as on different EU Projects. She is an expert in project management and financing of FP7 and H2020 projects. She speaks three languages including Bulgarian, Italian and English.
She attended High School in her hometown and finished it on 1992 with excellent results. She did successfully the competition and gained the right to follow university studies in Faculty of Medicine, in Tirana University (Albania). She obtained the diploma of Medical Doctor on 1998 with excellent results.
During 1999-2003 she attended the post graduated school on pediatrics residency in Tirana, Albania.
From 2004 she works as a lecturer in Faculty of Technical Medical Sciences, University of Medicine in Tirana. She holds the Vice Dean’s position and is a professor of Pediatrics and Medical genetics. She works as a pediatrician in University Hospital Center” Mother Teresa” Tirana, Center of Congenital Blood Diseases.
In 2011 she becomes Doctor of Science (PhD) in Pediatrics and from 2016 she is Associated Professor. Since 2015 she is a Medical Director in Consorzio per Valutazioni Biologiche e Farmacologiche in Tirana (part of CVBF Italy).
She has been part of many round tables and scientific sessions regarding haemoglobinopathies inside Albania and abroad. She has an enormous activity regarding writing of scientific articles and publications. She is Principal Investigator in a multicentric clinical study (DEferipron Evaluation in Paediatrics).
She is author of some academic textbooks: Textbook of Medical Genetics and elements of molecular biology, Textbook of Pediatrics (both for University students) and two monographs (one in English and one in Albanian).
Development & Networking Area Staff
Pharmacist by training, graduated at the University of Rome “Tor Vergata”, she is completing a master’s degree in Tropical Medicine and Global Health, at the Universities of Florence and Brescia.
She joined CVBF Training & Advocacy Area as intern, working at drafting a project proposal 8for an international tender.
Development & Networking Coordinator
Master’s Degree in Political Science, International Relations. Bachelor’s Degree in Foreign Languages - Linguistic Mediation in the European Union. She is responsible for Development and Networking in CVBF. She is involved in the communication and dissemination activities in several European projects (e.g. GAPP and DEEP) and responsible for the TEDDY Network (European Network of Excellence for Paediatric Clinical Research). She is responsible for the activities dedicated to patient’s advocacy and coordinates the KIDS Bari, the first Young Persons Advisory Group in Italy.
I obtained my degree in Mathematics and the PhD in Mathematics and Statistics at the University of Pavia. I worked as a data manager in clinical environment and then as a biostatistician at the University of Milan dealing in particular with the statistical evaluation of immune variables as prognostic biomarkers in tumor patients and clinical databases management.
In CVBF I am working as a biostatistician and I am collaborating with the data management and the clinical research area.
She is a researcher with over ten years of experience on clinical research. She started her professional experience in 2007 under a PhD in Pharmacological Sciences at the Department of Medicine of the University of Pavia. Concerning her background, she received a BA in Biological Sciences and a Master's degree in Neurobiology, both from Pavia University. She has come at CVBF since November 2018 and currently she is working primarily with the Pharmacovigilance and Regulatory Team as Regulatory Manager and Safety Contact but she is also involved in trial management and monitoring as Clinical Trial Assistant. Prior to CVBF she worked in Milan for the European Institute of Oncology as Data Manager and for San Raffaele Hospital as Senior Data Manager and Head of Training.
Regulatory and Pharmacovigilance Coordinator
Cristina is Coordinator of the Regulatory & Pharmacovigilance Area and Pharmacovigilance Deputy at CVBF.
Registered in EudraVigilance and Safety Contact in different paediatric clinical trials, she provides support to Project Managers and liaises with external parties on regulatory and pharmacovigilance needs and aspects.
Working at CVBF since 2004, she has also gained experience in project management.
Cristina holds a Master’s Degree in Marketing Communication and since she started her employment at CVBF she has attended specific training courses focused on the activities she is involved with and coordinates.
Giovanni Migliaccio is the Scientific Director of the Centro Valutazioni Biologiche e Farmacologiche, (CVBF Pavia, IT) and a Senior Advisor for the European Translational Medicine Research Infrastructure (EATRIS, Amsterdam NL).
He obtained a PhD in Biological science in 1977 at the University of Naples (Italy). His interest in science developed around stem cell proliferation and differentiation mechanisms. He spent two years as Post Doc at the University of Washington (Seattle, WA) and 5 years as Associate Scientist at the New York Blood Center (New York, NY). He continued his studies at the Istituto Superiore di Sanità (ISS) in Rome resulting in more than 150 scientific publications over the years.
He is involved in the regulatory aspects of using cultured cells as part of human therapies and acts as an expert for the Italian government in the area of Cell and Gene Therapies. He is also an expert for these products for the European Medicines Agency (EMA). He was also the Chair of the CTP group at the European Department for Quality of Medicines (EDQM) from 2010 to 2018.
Degree in Business administration. She is the Coordinator of the Administrative Unit and Office Manager at CVBF. Expert in financial reporting for FP7 and Horizon 2020 Projects, she is member of the Project Management Team for FP7 projects and Horizon 2020 Projects. Member of the Project Management Team and Financial Manager of ID-EPTRI Project, Administrative Manager of the DEEP Project, member of the DEEP Trial Management Team.
Musaraj has a degree in Pharmacy and is PhD in Biochemical and Pharmacological Sciences with scientific background in preclinical and clinical research. In CVBF, she is a member of the Innovation area in which provides support regarding scouting at European and national level and in particular she is involved in medical writing activities. In addition, she holds the role of Project Manager for pediatric studies on rare diseases.
Main activities: planning and management of clinical trials, contacts and contract negotiation with clinical centers, national and international project activities according to ICH / GCP standards and company regulations, preparation of Standard Operational Procedures (SOPs) and Study Specific Procedures (SSPs), management of regulatory and ethical issues with Competent Authorities and Ethics Committees, support activities related to the Investigational Product (IP) area, pharmacovigilance activities.
Clinical Research Associate & Data Management Coordinator
Degree in chemistry, she has several years of experience in Clinical Research. In CVBF she covers the role of Clinical Trial Project Manager and CRA in pediatrics and rare diseases trials, medical device and observational studies. Main area of activities: set-up of local/international project activities according to the company standards and regulations. Managing tasks/activities according to project-specific quality standards as well as relevant SOPs, ICH/GCP and local requirements. Preparation/Review of regulatory documentation for EC/AC submission. Editing and Review of trial documentations: protocol, CRF, ICF, IB. Contract negotiation and finalization with study sites.
Development & Networking Area Staff
Valeria Pignataro is a biotechnologist with a master degree in Medical Biotechnology and Molecular Medicine achieved at the University of Bari. She is also attending the Master on “Preclinical and clinical development of the drug: technical-scientific, regulatory and ethical aspects” at the Università Cattolica del Sacro Cuore in Rome.
She worked in the Drug Management team on two paediatric projects, DEEP-2 and GAPP, and in the regulatory and pharmacovigilance.
She is member of the TEDDY - European Network of Excellence for Paediatric Clinical Research, an independent Research Network, participating to the working groups: Off-label medicines use in paediatrics, Health data and Regulatory procedures for paediatric clinical trials.
Currently Valeria is member of the Project Management team of the ID-EPTRI project and Reference Person in CVBF of the Work Package 8 about “Paediatric Medicines Formulations and Medical Devices” and Work Package 9 related to the activities “Underpinning Medicines Development to Paediatric Studies”.
Clinical Research Associate & Trial Operations Coordinator, SOPs & Training
Degree in Pharmaceutical Chemistry and Technology, she worked 15 years in a pharmaceutical company first in Pre-Clinical Research, then in Clinical Research as monitor and associate manager for clinical trial management. From 2008, she collaborated with San Matteo Hospital in Pavia, for 9 years, working at the Scientific Secretary of the Ethics Committee. She was involved as part of the Clinical Trial Quality Team of the Hospital in activities for improvement of quality of non-profit studies. She also collaborated in the activation of the San Matteo Phase I Clinical Trial Unit.
In CVBF, she is responsible of Trial Management & Monitoring Area and she collaborates with Quality Assurance for preparation and revision of Standard Operating Procedures. She also acts as Project Manager for profit/non-profit studies.
Clinical Project Manager
Bianca Tempesta, PhD in Pharmacology and Toxicology, Master Degree in Industrial and Enviromental Biotechnology. Since 2015 Dr.Tempesta started working in CVBF on drug management and technical operation activities of multinational clinical studies within EU-funded projects (DEEP, GAAP). Moreover, she is currently involved in ID-EPTRI project funded within the H2020-INFRADEV-01-2017 programme, as CVBF representative in WP9 activities.