The resources operating in this area provide support in the application and the improvement of the quality system. In particular, the QA has the following tasks: Prepare and update the Quality Manual and the other SGQ documents, their release and diffusion; Collaborate to define the necessary actions for the SGQ monitoring and improvement; Verify the efficacy and the realization of the corrective and preventive actions; Handle any audit for the suppliers (general and professional services); Handle the control process on SGQ, planning the internal audits and keeping the records updated; Record the training activities of the collaborators and store the documentation. Moreover, he/she is responsible for: Preparing the standard operating procedures in order to guarantee that the clinical studies conducted by CVBF as Sponsor or CRO are conducted and the data are recorded in compliance with the protocol and with the GCP; Ensuring that the resources involved in the clinical studies are trained properly; Performing controls through internal procedures or in collaboration with external professionals on the activities and the documents related to the clinical studies and checking whether the activities have been carried out properly, and the data have been recorded, analysed and communicated in compliance with the protocol, the SOPs and the GCP; Performing controls during each phase of the data management in order to guarantee the reliability and the proper preparation of the data; The Office Managers (OMs) in Bari and Pavia are part of the QA Area and have the following tasks: Support the Direction for HR management and internal communication; Manage offices assuring availability and maintenance of facilities, hardware and software, utilities and consumables; Handle application and screening of CVs, planning interviews and providing feedback to the candidates; Guarantee to all resources appropriate work space, documents and information on the organization and its rules; Deal with all documentation related to the human resources, such as CVs, personal profiles, registries of presence; Keep the HR calendar updated with absences, missions, training courses, conferences, etc. Handle the application and the screening of the CVs, planning interviews and providing the feedback to the candidates;

The resources operating in this Area carry out the activities related to the project and the administrative management, and relate with the external consultants to ensure the fulfilment of the administrative and fiscal obligations. The main activities are: Deal with the management of the funded projects and support the Project Managers; Fill the reporting forms of the projects and store the support documentation; Manage the qualification process of suppliers and verify purchase orders before submitting to the signature of the relevant functions (arrange purchase orders and deal with suppliers); Handle the purchase processes, from the estimates acquisition to the proper execution of the supplies; Perform cash checks, banks, and purchase / sales bills; Deal with the receipts and payments; Store the contract documents and the copy of the accounting, financial and administrative documents related to the clients and suppliers, personnel and collaborators, partners and reference institutions; Directly manage or provide external consultants with all the data necessary for the upgrade of accounting records, the preparation of the financial fulfilments, as well as the revision activities; Handle the mail, legal mail, protocol and archives.

The Area Coordinator refers to the activities of his/her area of expertise and reports to the Direction on the qualification and development of resources. His/her tasks are: support CVBF activities in his/her competence field towards external subjects and within the organization; monitor the development of the activities within the area in terms of quality and quantity and suggest to the Direction the actions to solve any issue to foster the development; deal with the professional improvement of HR in the area and submit the training plans to the Direction for approval; suggest to the Direction a plan of renewal of working methodologies, goods and services for the activities of the Area.

The Project Manager ensures the respect of the timing and the results foreseen by the project, the production of the expected outputs and deliverables and the achievement of the technical-scientific objectives. The Project Manager guarantees the effective use of the resources, based on the budget of the project and the reference contract documentation. He/she reports to the Direction the progress and the achievement of the objectives, as well as the use of the resources and tools. The PM can be assisted by appointed administrative manager and collaborators for the project. In case of complex projects, further people can be identified as responsible for specific parts or work packages of the same project. Identify the strategic lines for the proper conduction of the project; Define the needs of the human resources (in terms of expertise and tasks), goods and services to be used for the project and submit the project budget to the Administrative Direction periodically Plan the development phases of the project and its controls; Monitor the activities of the team and provide the technical-methodological support; Relate to the Reference Direction about the expertise of the resources in order to suggest some changes; Delegate to the collaborators and any other appointed manager the execution of specific parts of the project; Monitor reports and results of the project, defining needed actions for any issue during the progress of the project; Interact with external referents identified for specific technical-scientific aspects of the project; Submit to the approval of the Scientific Direction relevant project’s document (deliverables, publications, etc); Submit to the approval of the Reference Direction the technical-scientific reports and any other documents, eventually along with the Scientific Direction approval.

The Projects Director carries out activities necessary to promote the growth of the projects and services provided by CVBF. In particular, he/she has the following tasks: Relate with the main CVBF partners and clients; Coordinate the activities of the organization along with the Administrative Director and delegate to the Areas Coordinators the specific activities they are responsible for; Define and appoint along with the Administrative Direction the team for each project, the roles, the responsibilities and the tasks of the team components, on the proposal of the Project Manager; Approve the technical-scientific reports prepared under the Project Managers responsibility; The Project Director is the Direction reference person for the following Areas: Quality Assurance, Information System, Regulatory & Pharmacovigilance, Trial Management & Monitoring, Research & Data Sharing.

The Scientific Director is part of the CVBF Direction together with the Administrative Director and the Projects Director, and he/she is in charge of addressing the CVBF scientific activities, collaborating to the programme and scientific activities preparation, also through the coordination of the Scientific Committee tasks. The Scientific Director: participate in meetings and congresses also in order to develop and maintain relationships with external strategic partners and stakeholders; reviews and approves the technical-scientific outputs of CVBF activities and the scientific publications; contributes with scientific inputs and contents to the development of new projects, since their submission to the concerned funding authorities or companies; Prepares and reviews the annual research plans of the CVBF; Suggests to the Board of Directors and the Assembly the programmatic lines for the development of the CVBF scientific activities..

Shareholder FAQ

Abstract and congress proceedingsGiuliana Palella2021-04-17T17:01:15+00:00

Abstract and congress proceedings

Toma M, Bonifazi F, Landi A, Cattani E, Giannuzzi V, Felisi M, Ceci A.
Orphan paediatric medicines in Europe.
R E(AC T) congress IRDiRC Conference International Congress of Research on Rare and Orphan Diseases – online – 13-15 January 2021 (84 abstract).

Denora N, Pignataro V, Lupo M, Migliaccio G, Bonifazi D, Ceci A.
Paediatric oral liquid formulations of sodium dichloroacetate for the acute and chronic treatment of acquired or congenital lactic acidosis.
R E(AC T) congress IRDiRC Conference International Congress of Research on Rare and Orphan Diseases – online – 13-15 January 2021 (82 abstract).

Bonifazi D, Musaraj K, Tushe A, Manfredi C, Felisi M.
Identification of available tools for the assessment of causality and severity in paediatric population.
18° World Congress of Basic and Clinical Pharmacology (WCP2018) – Kyoto (Giappone) 1-6 July 2018 (progetto PedCRIN).

Lucia Ruggieri, Maria Cavallo, Mariangela Lupo, Ludovica Frizziero, Maria Caterina Putti, Lorella Pitrolo, Floreta Kurti, Eleni Nastas, Manika Kreka, Jorida Zogaj, Ariana Zaka, Donato Bonifazi, Adriana Ceci on behalf of the DEEP consortium.
Ad hoc informative strategies as a crucial tool to empower children affected by haemoglobinopathies involved in a multinational clinical study.
14th International Conference on Thalassaemia & Haemoglobinopathies & 16th TIF International Conference for Patients & Parents. Thessaloniki, 17-19 November, 2017

Felisi M, Gambino A, Baiardi P, Bonifazi D, Anastasi S, Borsellino Z, Spasiano A, Piraino B, Gerardi C, Musso R, Pitrolo L, Romeo MA, Campisi S, Rizzo M, Ceci A, Maggio A on behalf of HTA THAL project.
Combined ICT in adolescent and adults population in Italy: results from the HTA-THAL Registry.
Italian Red Cell Club 2014 – Naples, 3-4 October 2014

Mangiarini L, Padula R, Bonifazi D, Del Vecchio G, Baiardi P.
The multiregional Italian Thalassemia Registry: patient’s population changes and related iron chelation approach.
13th International Conference on Thalassaemia – Abu Dhabi, 20-23 October 2013

Ceci A, Mangiarini L, Catapano M, Manfredi C, Felisi M, Knibbe CA, Neubert A, Tibboel D, Della Pasqua O, Benini F.
Paediatric therapeutic needs in the treatment of pain: how to address them and be successful.
1° European Congress on Paediatric Palliative Care – Rome 20-30 November 2012

Baiardi P, Ceci A, Cantarutti L, Girotto S, Sturkenboom M, Baraldi E.
How the European paediatric regulation is reducing the gap.
Acta Paediatr. 2010 Jun 1; 99(10):1446.

Felisi M, Cella M, Ceci A.
Studio pilota su sostanze d’abuso usate nello sport da giovani studenti italiani, realizzato mediante una piattaforma informatica creata ad hoc.
XXXII Congresso Nazionale SIF – Società Italiana di Farmacologia. Naples, 1-4 June 2005

Ceci A.
Abuso e maluso di farmaci in età scolare: interventi formative e preventive.
II Corso Interdisciplinare di Aggiornamento in Adolescentologia Genova – 4/5 April 2005. Scuola Internazionale di Scienze Pediatriche

Baiardi P, Bonifazi F, Felisi MG, Ceci A.
Active monitoring of safety through a rare disease register.
XXX Congresso Nazionale SIF, Genoa, 30 May-2 June, 2001

Felisi MG, Baiardi P, Ceci A.
Pharmacovigilance of deferiprone through the Italian Register for the Controlled Use.
XXX Congresso Nazionale SIF, Genoa, 30 May-2 June, 2001

Books and Book ChaptersGiuliana Palella2022-02-28T11:00:01+00:00

Books and Book Chapters

Giannuzzi V, Musaraj K.
L’uso off-label dei farmaci in pediatria.
Quaderni della SIF: 2019; Anno XV-nr. 46, (3-5).

Intini A, Bonifazi D, Migliaccio G.
Challenges and New Frontiers in the Paediatric Drug Discovery and Development.
Drug Discovery and Development – New Advances. Publisher: IntechOpen 2019. (Published on-line)

Lupo M, Intini A, Filannino D.
Informed Participation and Patient Empowerment: A Patient-Centered Approach to Improve Pediatric Clinical Research.
The Management of Clinical Trials. Publisher: Intech 2018, 35-51.

Chiaruttini G, Felisi M, Bonifazi D.
Challenges in paediatric clinical trials: how to make it feasible.
The Management of Clinical Trials. Publisher: Intech 2018, 11-33.

Ceci A, Giannuzzi V, Bonifazi D, Felisi M, Bonifazi F, Ruggieri L.
Clinical Trials in Paediatrics — Regulatory and Methodological Aspects.
Drug Discovery and Development – From Molecules to Medicine, Edited by Omboon Vallisuta and Suleiman Olimat, Publisher: InTech, June 2015;(12):272-297.

Chaplin JE and the RESPECT project partners: Crawley FP, Sanna L, Ceci A, Neubauer D, Giaquinto C, Chaplin C, Bullinger M.
RESPECT patient needs. Relating expectations and needs to the participation and empowerment of children in clinical trials.
Pabst Science Publisher 2012

Ceci A, Catapano M, Manfredi C, Wong I, Orlu-Gul M, Meneguz M, Baiardi P, Della Pasqua O, Iolascon A, Scarpa M, Neubert A.
Changes in Research and Development of Medicinal Products since the Paediatric Regulation.
Drug Development – A Case Study Based Insight into Modern Strategies. Edited by Chris Rundfeldt, Publisher: InTech, December 2011;585-638.

Valverde JL and Ceci A (Eds).
Innovative medicine: the science and the regulatory framework.
Pharmaceuticals Policy and Law, 2010;12(1,2).

Ceci A.
La sperimentazione in pediatria.
Borgia LM, C.G Edizioni Medico Scientifiche (eds). Manuale di Bioetica per la Sperimentazione clinica e i Comitati Etici: 2008;(14)415-37.

Ceci A.
Gli aspetti medico biologici.
Ministero della Pubblica Istruzione. “Prevenire il Doping tra gli studenti” Manuale per gli insegnanti. Roma: 2001:119-170.

ArticlesGiuliana Palella2023-04-28T09:03:31+00:00

Articles

2023

Reggiardo G, Lo Giudice M, Lalli S, Rinaldi G, Albanese A.
Cox regression and survival analysis from the tauro-urso-deoxycholic trial in amyotrophic lateral sclerosis
Front. Neurol., 20 April 2023, Sec. Dementia and Neurodegenerative Diseases, Volume 14 – 202, doi.org/10.3389/fneur.2023.1163855

Giannuzzi V, Ruggieri L, Conte R, Manfredi C, Felisi M, Kubiak C, Matei M, Malik S, Demotes J, Ceci A, Bonifazi D.
PedCRIN tool for the biosamples management in paediatric clinical trials
Clin Transl Sci. 2023 Feb 9. doi: 10.1111/cts.13489. Online ahead of print.

2022

Lederer C.W, Koniali L, Buerki-Thurnherr T, Papasavva P.L, La Grutta S, Licari A, Staud F, Bonifazi D, Kleanthous M.
Catching Them Early: Framework Parameters and Progress for Prenatal and Childhood Application of Advanced Therapies
Pharmaceutics 2022, 14, 793. doi.org/10.3390/pharmaceutics14040793

Sultana J, Crisafulli S, Almas M, Antonazzo I, Baan E, Bartolini C, Bertuccio MP, Bonifazi F, Capuano A, Didio A, Ehrenstein V, Felisi MG, Ferrajolo C, Fontana A, Francisca R, Fourrier-Reglat A, Fortuny J, Gini R, Hyeraci G, Hoeve C, Kontogiorgis C, Isgrò V, Lalagkas PN, L’Abbate L, Layton D, Landi A, Narduzzi S, Roque Pereira L, Poulentzas G, Rafaniello C, Roberto G, Scondotto G, Sportiello L, Toma M, Toussi M, Verhamme K, Volpe E, Trifirò G
Overview of the EU PAS register post-authorization studies performed in Europe from September 2010 to December 2018
Pharmacoepidemiol Drug Saf 2022 Jan 29. doi: 10.1002/pds.5413. Online ahead of print

Caminiti C, Maglietta G, Frau I, Peruzzotti G, Felisi M, van Dijk A and on behalf of AICRO’s Clinical Trial Center Working Group (WG-CTC)
Presence and activities of clinical research coordinators at Italian Health Care Institutions: A national cross-sectional survey
Journal of Clinical and Translational Science 2022 Jan 24; 6:e1, 1–7. doi: 10.1017/cts.2021.872

2021

Sainz T, Pignataro V, Bonifazi D, Ravera S, José Mellado M, Pérez-Martínez A, Escudero A, Ceci A, Calvo C
Human Microbiome in Children, at the Crossroad of Social Determinants of Health and Personalized Medicine
Children (Basel) 2021 Dec; 8(12): 1191. Published online 2021 Dec 16

Giannuzzi V, Felisi M, Bonifazi D, Devlieger H, Papanikolaou G, Ragab L, Fattoum S, Tempesta B, Reggiardo G, Ceci A
Ethical and procedural issues for applying researcher-driven multi-national paediatric clinical trials in and outside the European Union: the challenging experience of the DEEP project
BMC Med Ethics. 2021; 22: 49. Published online 2021 Apr 29. doi: 10.1186/s12910-021-00618-2

Ruggieri L, Ceci A, Bartoloni F, Elie V, Felisi M, Jacqz-Aigrain E, Lupo M, Malik S, Manfredi C, Reggiardo G, Demotes J, Bonifazi D.
Paediatric clinical research in Europe: an insight on experts’ needs and perspectives
Contemporary Clinical Trials Communications 21 (2021) 100735

Lupo M, Akuffo E, Lettieri M, Bonifazi D, Marini S, Dehlinger-Kremer M.
The Current Status of European Research Related to COVID-19: The EUCROF Perspective
2021 MJH Life Sciences and Applied Clinical Trials

Toma M, Felisi M, Bonifazi D, Bonifazi F, Giannuzzi V, Reggiardo G, de Wildt S, Ceci A and TEDDY European Network of Excellence for Paediatric Research.
Paediatric Medicines in Europe: The Paediatric Regulation – Is It Time for Reform?
Front. Med., 02 February 2021 | Vol. 8 https://doi.org/10.3389/fmed.2021.593281

2020

Aurich B, Vermeulen E, Elie V, Driessens MHE, Kubiak C, Bonifazi D, Jacqz-Aigrain E.
Informed consent for neonatal trials: practical points to consider and a check list.
BMJ Paediatrics Open. 29 December 2020; doi.org/10.1136/bmjpo-2020-000847

de Leeuw TG, van der Zanden T, Ravera S, Felisi M, Bonifazi D, Tibboel D, Ceci A, Kaguelidou F, de Wildt SN; GAPP Consortium.
Diagnosis and Treatment of Chronic Neuropathic and Mixed Pain in Children and Adolescents: Results of a Survey Study amongst Practitioners.
Children (Basel) 2020 Nov; 7(11): 208 doi: 10.3390/children7110208

Turner MA, Cheng K, de Wildt S, Hildebrand H, Attar S, Rossi P, Bonifazi D, Ceci A, Claverol J, Nafria B, Giaquinto C.
European research networks to facilitate drug research in children.
Br J Clin Pharmacol. 2020 Sep 6. doi: 10.1111/bcp.14545. Online ahead of print.

Maggio A, Kattamis A, Felisi M, Reggiardo G, El-Beshlawy A, Bejaoui M, Sherief L, Christou S, Cosmi C, Della Pasqua O, Del Vecchio GC, Filosa A, Cuccia L, Hassab H, Kreka M, Origa R, Putti MC, Spino M, Telfer P, Tempesta B, Vitrano A, Tsang YC, Zaka A, Tricta F, Bonifazi D, Ceci A.
Evaluation of the efficacy and safety of deferiprone compared with deferasirox in paediatric patients with transfusion-dependent haemoglobinopathies (DEEP-2): a multicentre, randomised, open-label, non-inferiority, phase 3 trial.
Lancet Haematol. 2020 Jun;7(6):e469-e478.

2019

Ruggieri L, Bonifazi D, Landi A, Bonifazi F, Bartoloni F, Costello M, Felisi MG, Gasthuys E, Godo A, Martinon Torres F, Nadal D, Nuytinck L, Rocchi F, Turner M, Ceci A.
Survey by TEDDY European Network of Excellence for Paediatric Clinical Research demonstrates potential for Europe-wide trials.
Acta Paediatr. 2019 Sep 18. doi: 10.1111/apa.15020.

Ceci A, Conte R, Didio A, Bonifazi D, Felisi M, Giannuzzi V, Bonifazi F.
An overview of the efficacy and safety of deferiprone in paediatric patients with congenital haemoglobinopathies and chronic iron overload.
Expert Opinion on Orphan Drugs, 2019;7(4):181-197.

Kaguelidou F, Le Roux E, Mangiarini L, Lundin R, de Leeuw TG, Della Pasqua O, Felisi M, Bonifazi D, Tibboel D, Ceci A, de Wildt SN, Alberti C; GAPP consortium.
Non-inferiority double-blind randomised controlled trial comparing gabapentin versus tramadol for the treatment of chronic neuropathic or mixed pain in children and adolescents: the GABA-1 trial-a study protocol.
BMJ Open. 2019 Feb 20;9(2):e023296. doi: 10.1136/bmjopen-2018-023296.

Orlando G, Murphy S, Bussolati B, Clancy M, Migliaccio G, Murray P.
Rethinking Regenerative Medicine From a Transplant Perspective (and Vice Versa).
Transplantation. 2019 Feb;103(2):237-249

2018

Ranucci G, Buccigrossi V, Borgia E, Piacentini D, Visentin F, Cantarutti L, Baiardi P, Felisi M, Spagnuolo MI, Zanconato S, Baraldi E, Giaquinto C, Guarino A.
Galacto-Oligosaccharide/Polidextrose Enriched Formula Protects against Respiratory Infections in Infants at High Risk of Atopy: A Randomized Clinical Trial.
Nutrients. 2018 Mar 1;10(3).

Boulkedid R, Abdou AY, Desselas E, Manégat M, de Leeuw TG, Avez-Couturier J, Dugue S, Mareau C, Charron B, Alberti C, Kaguelidou F; GAPP Consortium.
The research gap in chronic paediatric pain: A systematic review of randomised controlled trials.
Eur J Pain. 2018 Feb;22(2):261-271 Review.

Botzenhardt S, Felisi M, Bonifazi D, Del Vecchio GC, Putti MC, Kattamis A, Ceci A, Wong ICK, Neubert A; DEEP consortium (collaborative group).
Long-term safety of deferiprone treatment in children from the Mediterranean region with beta-thalassemia major: the DEEP-3 multi-center observational safety study.
Haematologica. 2018 Jan;103(1): e1-e4.

2017

Giannuzzi V, Landi A, Bosone E, Giannuzzi F, Nicotri S, Torrent-Farnell J, Bonifazi F, Felisi M, Bonifazi D, Ceci A.
Failures to further developing orphan medicinal products after designation granted in Europe: an analysis of marketing authorisation failures and abandoned drugs.
BMJ Open. 2017 Sep 11;7(9): e017358.

Veal GJ, Malik A, Lupo M, MacFarlane S, Lepola P, Costello M, Ceci A, Boué C, Lecour C, Otto A, Rastegari M, Berry P.
Investigating the roles and training of paediatric research nurses working across Europe: a questionnaire-based survey
BMJ Paediatrics Open 2017;1: e000170.

Bonifazi F, Conte R, Baiardi P, Bonifazi D, Felisi M, Giordano P, Giannuzzi V, Iacono A, Padula R, Pepe A, Caterina Putti M, Ruggieri L, Carlo Del Vecchio G, Filosa A, Maggio A, Ceci A; HTA-THAL Multiregional Registry.
Pattern of complications and burden of disease in patients affected by beta thalassemia major.
Curr Med Res Opin. 2017 Aug;33(8):1525-1533.

A. van Dijk, S. Sacchi on behalf of the Working Group (Donato Bonifazi, Vittorio Carrera, Mariagrazia Felisi, Mariangela Lupo, Stefano Marini e Lisa Parigi, Angela Del Vecchio, Caterina Caminiti, Francesca Diodati, Elisa Iezzi, Giuseppe Maglietta, Barbara Marcomini, Veronica Rossolini, Giovanni Gori, Fulvio Ferrara, Silvano Berioli, Mario Fraticelli, Eleonora Sfreddo, Yvonne Cernò, Antonino Amato, Luca Angerame, Elena Carafelli, Marina Cicerone, Betty Polikar, Margherita Zona, Roberto Poscia, Umberto Filibeck).
White Paper AICRO – Working Group Clinical Trial Centers.
AICRO – Working Group CTC May 15, 2017

Giannuzzi V, Conte R, Landi A, Ottomano SA, Bonifazi D, Baiardi P, Bonifazi F, Ceci A.
Orphan medicinal products in Europe and United States to cover needs of patients with rare diseases: an increased common effort is to be foreseen.
Orphanet J Rare Dis. 2017 Apr 3;12(1):64.

Bellanti F, Del Vecchio GC, Putti MC, Maggio A, Filosa A, Cosmi C, Mangiarini L, Spino M, Connelly J, Ceci A, Della Pasqua O; Consortium DEferiprone Evaluation in Paediatrics (DEEP).
Population pharmacokinetics and dosing recommendations for the use of deferiprone in children younger than 6 years.
Br J Clin Pharmacol. 2017 Mar;83(3):593-602.

Giannuzzi V, Devlieger H, Margari L, Odlind VL, Ragab L, Bellettato CM, D’Avanzo F, Lampe C, Cassis L, Cortès-Saladelafont E, Cazorla ÁG, Barić I, Cvitanović-Šojat L, Fumić K, Dali CI, Bartoloni F, Bonifazi F, Scarpa M, Ceci A.
The ethical framework for performing research with rare inherited neurometabolic disease patients.
Eur J Pediatr. 2017 Mar;176(3):395-405. doi: 10.1007/s00431-017-2852-9. Epub 2017 Jan 16. Review.

2016

Murgia A, Veronesi E, Candini O, Caselli A, D’souza N, Rasini V, Giorgini A, Catani F, Iughetti L, Dominici M, Burns JS.
Potency Biomarker Signature Genes from Multiparametric Osteogenesis Assays: Will cGMP Human Bone Marrow Mesenchymal Stromal Cells Make Bone?
PLoS One. 2016 Oct 6;11(10):e0163629.

Smania G, Baiardi P, Ceci A, Cella M, Magni P.
Model-Based Assessment of Alternative Study Designs in Pediatric Trials. Part II: Bayesian Approaches. CPT.
Pharmacometrics Syst Pharmacol. 2016 Aug;5(8):402-10.

Baldissarro E, Aquilani R, Boschi F, Baiardi P, Iadarola P, Fumagalli M, Pasini E, Verri M, Dossena M, Gambino A, Cammisuli S, Viglio S.
The Hip Functional Retrieval after Elective Surgery May Be Enhanced by Supplemented Essential Amino Acids.
BioMed Research International, vol. 2016, Article ID 9318329, 10 pages, 2016.

Conte R, Ruggieri L, Gambino A, Bartoloni F, Baiardi P, Bonifazi D, Bonifazi F, Felisi M, Giannuzzi V, Padula R, Pepe A, Putti MC, Del Vecchio GC, Maggio A, Filosa A, Iacono A, Mangiarini L, Ceci A.
The Italian multiregional thalassemia registry: Centers characteristics, services, and patients’ population.
Hematology. 2016 Aug;21(7):415-24.

Botzenhardt S, Sing CW, Wong IC, Chan GC, Wong LY, Felisi M, Rascher W, Ceci A, Neubert A.
Safety Profile of Oral Iron Chelator Deferiprone in Chinese Children with Transfusion-dependent Thalassaemia.
Curr Drug Saf. 2016;11(2):137-44.

2015

Ruggieri L, Giannuzzi V, Baiardi P, Bonifazi F, Davies EH, Giaquinto C, Bonifazi D, Felisi M, Chiron C, Pressler R, Rabe H, Whitaker MJ, Neubert A, Jacqz-Aigrain E, Eichler I, Turner MA, Ceci A; on behalf of the GRiP Consortium.
Successful private-public funding of paediatric medicines research: lessons from the EU programme to fund research into off-patent medicines.
Eur J Pediatr. 2015 174(4):481-91.

2014

Bonifazi E, Milano A, Gambino A.
Prevention and treatment of hemangioma rebound after discontinuation of propranolol.
Eur. J. Pediat. Dermatol. 2014;(24) 35-43.

Aquilani R, D’Antona G, Baiardi P, Gambino A, Iadarola P, Viglio S, Pasini E, Verri M, Barbieri A, Boschi F.
Essential amino acids and exercise tolerance in elderly muscle-depleted subjects with chronic diseases: a rehabilitation without rehabilitation?
Biomed Res Int. 2014; 2014:341603.

Ceci A, Mangiarini L, Bonifazi F, Conte R, on behalf of the HTA-THAL Multiregional Registry.
Multidisciplinary care in haemoglobinopathies.
Thalassemia Reports. 2014; 4(3)68-74.

Turner MA, Catapano M, Hirschfeld S, Giaquinto C; Global Research in Paediatrics.
Paediatric drug development: the impact of evolving regulations.
Adv Drug Deliv Rev. 2014 Jun;73:2-13.

2012

Mellado Peña MJ, Piñeiro Pérez R, Medina Claros AF, Ceci A.
Use, implementation and impact of the TEDDY network in Europe.
Farm Hosp. 2012 Mar-Apr;36(2):109-10.

Altavilla A, Manfredi C, Baiardi P, Dehlinger-Kremer M, Galletti P, Pozuelo AA, Chaplin J, Ceci A.
Impact of the new european paediatric regulatory framework on ethics committees: overview and perspectives.
Acta Paediatr. 2012 Jan;101(1): e27-32.

2011

Maggio A, Filosa A, Vitrano A, Aloj G, Kattamis A, Ceci A, Fucharoen S, Cianciulli P, Grady RW, Prossomariti L, Porter JB, Iacono A, Cappellini MD, Bonifazi F, Cassarà F, Harmatz P, Wood J, Gluud C.
Iron chelation therapy in thalassemia major: A systematic review with meta-analyses of 1520 patients included on randomized clinical trials.
Blood Cells Mol Dis. 2011 Oct 15;47(3):166-75.

Lutsar I, Trafojer UM, Heath PT, Metsvaht T, Standing J, Esposito S, de Cabre VM, Oeser C, Aboulker JP; NeoMero Consortium. Collaborators (12) Giaquinto C, Rossi P, Esposito S, Sharland M, Aboulker J, Heininger U, Lutsar I, Roilides E, Warris A, Usonis V, Terés FO, Ceci A.
Meropenem vs standard of care for treatment of late onset sepsis in children of less than 90 days of age: study protocol for a randomised controlled trial.
Trials. 2011 Sep 30;12:215.

Ceci A, Mangiarini L, Felisi M, Bartoloni F, Ciancio A, Capra M, D’Ascola D, Cianciulli P, Filosa A.
The management of iron chelation therapy: preliminary data from a national registry of thalassaemic patients.
Anemia. 2011; 2011:435683.

Sen EF, Verhamme KM, Felisi M, ‘t Jong GW, Giaquinto C, Picelli G, Ceci A, Sturkenboom MC; TEDDY European Network of Excellence.
Effects of safety warnings on prescription rates of cough and cold medicines in children below 2 years of age.
Br J Clin Pharmacol. 2011 Jun;71(6):943-50.

Baiardi P, Giaquinto C, Girotto S, Manfredi C, Ceci A; on behalf of the TEDDY Network of Excellence.
Innovative study design for paediatric clinical trials.
Eur J Clin Pharmacol. 2011 May;67 Suppl 1:109-15.

Sen EF, Verhamme KM, Neubert A, Hsia Y, Murray M, Felisi M, Giaquinto C, ‘t Jong GW, Picelli G, Baraldi E, Nicolosi A, Ceci A, Wong IC, Sturkenboom MC; on behalf of the TEDDY European Network of Excellence.
Assessment of Pediatric asthma drug use in three European countries; a TEDDY study.
Eur J Pediatr. 2011 Jan;170(1):81-92

2010

Neubert A, Verhamme K, Murray ML, Picelli G, Hsia Y, Sen FE, Giaquinto C, Ceci A, Sturkenboom M, Wong IC; TEDDY Network of Excellence.
The prescribing of analgesics and non-steroidal anti-inflammatory drugs in paediatric primary care in the UK, Italy and the Netherlands.
Pharmacol Res. 2010 Sep;62(3):243-8.

Rocchi F, Paolucci P, Ceci A, Rossi P.
The european paediatric legislation: benefits and perspectives.
Ital J Pediatr. 2010 Aug 17;36:56.

Hsia Y, Neubert A, Sturkenboom MC, Murray ML, Verhamme KM, Sen F, Giaquinto C, Ceci A, Wong IC; on behalf of the TEDDY Network of Excellence.
Comparison of antiepileptic drug prescribing in children in three European countries.
Epilepsia. 2010 May;51(5):789-96.

Baiardi P, Ceci A, Felisi M, Cantarutti L, Girotto S, Sturkenboom M, Baraldi E.
In-label and off-label use of respiratory drugs in the Italian paediatric population.
Acta Paediatr. 2010 Apr;99(4):544-9.

2009

Ceci A, Giaquinto C, Aboulker JP, Baiardi P, Bonifazi F, Della Pasqua O, Nicolosi A, Taruscio D, Sturkenboom M, Wong I.
The Task-force in Europe for Drug Development for the Young (TEDDY) Network of Excellence.
Paediatr Drugs. 2009;11(1):18-21.

Papers within the TEDDY monograph (The EU Paediatric Regulation):

Ceci A.
TEDDY Network of excellence: Monograph on paediatric medicines
Pharmaceuticals Policy and Law, 2009;11(1,2):11-12.
Ceci A, Baiardi P, Bonifazi F, Giaquinto C, Mellado Pena MJ, Mincarone P, Nicolosi A, Sturkenboom M, Wong I.
TEDDY NoE project in the framework of the EU paediatric regulation
Pharmaceuticals Policy and Law, 2009;11(1,2):13-21
Krekelsa E, Ceci A, Iolascon A, Girotto S, Della Pasqua O.
The role of paediatric pharmacogenetic studies in Europe
Pharmaceuticals Policy and Law, 2009;11(1,2):23-30
Felisi M, Padula R, Bartoloni F, Grosch-Worner I, Kagedal B, Mellado Pena MJ, Parry J, Stuchlik A, Verhamme K, Ceci A.
TEDDY EPMD: A European paediatric medicines database
Pharmaceuticals Policy and Law, 2009;11(1,2):31-39
Neubert A, Felisi M, Bonifazi A, Manfredi C, Wong ICK, Ceci A.
Off-label and unlicensed use of medicines for children
Pharmaceuticals Policy and Law, 2009;11(1,2):41-49
Sturkenboom M, Felisi M, Manfredi C, Neubert A, Cantarutti L, Padula R, Sen F, Verhamme K.
Paediatric status and off-label use of drugs in children in Italy, United Kingdom and the Netherlands
Pharmaceuticals Policy and Law, 2009;11(1,2):51-59
Catapano M, Manfredi C, Paolucci P, Cross H, Verhamme K, Mellado Pena MJ, Grosch-Worner I, Knibbe C, Ceci A.
Recommendation for drug development for children
Pharmaceuticals Policy and Law, 2009;11(1,2):61-70
Baiardi P, Girotto S, Della Pasqua O, Harper L, Grosch-Worner I, Ceci A, Giaquinto C.
Clinical trials for paediatric medicines in Europe
Pharmaceuticals Policy and Law, 2009;11(1,2):71-78
Altavilla A, Giaquinto C, Giocanti D, Manfredi C, Aboulker JP, Bartoloni F, Cattani E, Lo Giudice M, Mellado Pena MJ, Nagler R, Peterson C, Vajnerova O, Bonifazi F, Ceci A.
Activity of ethics committees in Europe on issues related to clinical trials in paediatrics: Results of a survey
Pharmaceuticals Policy and Law, 2009;11(1,2):79-87
Verhamme K, Bonifazi F, Ceci A, Elferink-Stinkens P, Murray M, Neubert A, Nicolosi A, Stricker B, Wong I, Sturkenboom M.
Adverse drug reactions reporting in children
Pharmaceuticals Policy and Law, 2009;11(1,2):89-98
Trama A, Pierannunzio D, Loizzo A, Domenica Taruscio D, Ceci A.
Availability of medicines for rare diseases in EU countries
Pharmaceuticals Policy and Law, 2009;11(1,2):101-109

2008

Neubert A, Sturkenboom MC, Murray ML, Verhamme KM, Nicolosi A, Giaquinto C, Ceci A, Wong IC; TEDDY Network of Excellence.
Databases for pediatric medicine research in Europe–assessment and critical appraisal.
Pharmacoepidemiol Drug Saf. 2008 Dec;17(12):1155-67.

Neubert A, Wong IC, Bonifazi A, Catapano M, Felisi M, Baiardi P, Giaquinto C, Knibbe CA, Sturkenboom MC, Ghaleb MA, Ceci A.
Defining off-label and unlicensed use of medicines for children: Results of a Delphi survey.
Pharmacol Res. 2008 Nov-Dec;58(5-6):316-22.

Poggi G, Quaretti P, Minoia C, Bernardo G, Bonora MR, Gaggeri R, Ronchi A, Saluzzo CM, Azzaretti A, Rodolico G, Montagna M, Amatu A, Teragni C, Palumbo I, Traverso E, Tonini S, Villani L, Scelsi M, Baiardi P, Felisi MG, Sottotetti F, Tagliaferri B, Riccardi A.
Transhepatic arterial chemoembolization with oxaliplatin-eluting microspheres (OEM-TACE) for unresectable hepatic tumors.
Anticancer Res. 2008 Nov-Dec;28(6B):3835-42.

Sturkenboom MC, Verhamme KM, Nicolosi A, Murray ML, Neubert A, Caudri D, Picelli G, Sen EF, Giaquinto C, Cantarutti L, Baiardi P, Felisi MG, Ceci A, Wong IC; TEDDY European Network of Excellence.
Drug use in children: cohort study in three European countries.
BMJ. 2008 Nov 24;337:a2245.

Altavilla A, Giaquinto C, Ceci A.
European survey on ethical and legal framework of clinical trials in paediatrics: results and perspectives.
J Int Bioethique. 2008 Sep;19(3):17-48, 121-2.

Paolucci P, Jones KP, del Carmen Cano Garcinuno M, Catapano M, Iolascon A, Ceci A.
Challenges in prescribing drugs for children with cancer.
Lancet Oncol. 2008 Feb;9(2):176-83.

2007

Krekels EH, van den Anker JN, Baiardi P, Cella M, Cheng KY, Gibb DM, Green H, Iolascon A, Jacqz-Aigrain EM, Knibbe CA, Santen GW, van Schaik RH, Tibboel D, Della Pasqua OE.
Pharmacogenetics and paediatric drug development: issues and consequences to labelling and dosing recommendations.
Expert Opin Pharmacother. 2007 Aug;8(12):1787-99.

Sturkenboom M, Fatma E, Verhamme K, Herings R, Neubert A, Felisi M, Ceci A.
The Teddy Network: epidemiological trends in paediatric drug use in Europe.
EJHP Practice 2007; 13(6):22-24.

2006

Ceci A, Felisi M, Baiardi P, Bonifazi F, Catapano M, Giaquinto C, Nicolosi A, Sturkenboom M, Neubert A, Wong I.
Medicines for children licensed by the European Medicines Agency (EMEA): the balance after 10 years
Eur J Clin Pharmacol 2006. Nov;62(11):947-52.

Ceci A, Baiardi P, Catapano M, Felisi M, Cianciulli P, De Sanctis V, Del Vecchio GC, Magnano C, Meo A, Maggio A.
Risk factors for death in patients with beta-thalassemia major: results of a case-control study.
Haematologica. 2006 Oct;91(10):1420-1.

Ceci A, Giannino ML.
La farmacocinetica in pediatria: uno strumento importante per un giusto approccio terapeutico.
Area Pediatrica 2006; 8:39-44.

Ceci A.
Un nuovo Regolamento Europeo per le Medicine Pediatriche.
Occhio Clinico Pediatria, 2006; 1:2-3.

2005

Ceci A.
Legislazione e criticità nella sperimentazione dei farmaci.
Monitor, 2005; 12(IV):67-71.

Ceci A.
Esigenze di sperimentazione clinica di psicofarmaci per uso pediatrico.
Prospettive in Pediatria 2005; 35:221-229.

2004

Ceci A.
Significato e ruolo della farmacovigilanza in età pediatrica.
Occhio Clinico Pediatria, 2004; 9:264-269.

Ceci A, Baiardi P, Ravera S, Chiò E, Pellegri C, Negrini C, Capitelli G, Cela R, Corda G, Gaia E, Gozzi S, Marocchino F, Marrazzo E, Pizzini A, Ravaglia A, Sullo F, Tonini M.
Impiego degli Inibitori della Pompa Protonica (IPP) in Piemonte: indagine sulle abitudini prescrittive dei Medici di medicina Generale.
Farmeconomia e percorsi terapeutici 2004; 5(2):39-51.

2003

Ceci A, Felisi M, De Sanctis V, De Mattia D.
Pharmacotherapy of iron overload in thalassaemic patients.
Expert Opin Pharmacother. 2003 Oct;4(10):1763-74.

2002

Ceci A, Felisi M, Catapano M, Baiardi P, Cipollina L, Ravera S, Bagnulo S,Reggio S, Rondini G.
Medicines for children licensed by the European Agency for the Evaluation of Medicinal Products.
Eur J Clin Pharmacol. 2002 Nov;58(8):495-500.

Cipollina L, Folino-Gallo P, Grande D, Felisi M, Ravera S, Ceci A.
Mutua disponibilità, prezzi e rimborsabilità di farmaci autorizzati con procedura centralizzata europea.
Farmacoeconomia e percorsi terapeutici, 2002; 3(1): 15-27.

Ceci A, Baiardi P, Felisi M, Cappellini MD, Carnelli V, De Sanctis V, Galanello R, Maggio A, Masera G, Piga A, Schettini F, Stefano I, Tricta F.
The safety and effectiveness of deferiprone in a large-scale, 3-year study in Italian patients.
Br J Haematol. 2002 Jul;118(1):330-6.

Baiardi P, Felisi M, Cipollina L, Lerro G, Carnelli V, Rondini G, Ceci A.
Availability of paediatric medicines in Italy.
Quaderni di Pediatria, 2002:1(3):203-206

2001

Ceci A., Felisi M., Ravera S.
Farmacovigilanza in Pediatria.
Rubrica Mensile di Area Pediatrica, 2001-2008.

Research and Data SharingGiuliana Palella2021-04-17T16:56:03+00:00

Research and Data Sharing

CVBF provides its expertise for the creation and development of IT systems allowing efficient sharing of research data,
generated at national and international level both in the context of preclinical and clinical research and in medical practice.
The main activities are aimed at promoting paediatric “technology-driven” research characterized by a more efficient and conscious use of data at European level. The data are processed in compliance with current regulations (General Data Protection Regulation, GDPR) with regard to privacy and security and IT solutions are adopted using the most common standards for encoding and collecting data and information, ensuring at the same time the uniformity of the collected data and the interoperability between different platforms.

Trial Management and MonitoringGiuliana Palella2021-04-17T16:56:03+00:00

Trial Management and Monitoring

The trial management activity includes the activation of the clinical centres, coordination and support to all the functions in the clinical studies, the planning of the monitoring activities, of the Investigator meetings and of the study team meetings. The monitoring activities consist in the supervision of the trend of the clinical study in order to guarantee that the study is conducted, recorded and reported in compliance with the protocol, the Standard Operative Procedures (SOP) and the Good Clinical Practice (GCP). In particular, such activities include the monitoring visits as well as the redaction of the reports (qualification, initiation, monitoring, close-out).
The drug management activities consist in the coordination of the logistic processes of the IMP involved in the clinical trials, support the clinical Centres in the processes of storage, utilization and destruction of the IMP, in accordance with the protocol, the SOP and the GCP.
Management of data archives collected during clinical trial and clinical databases by means of specific controls intended to guarantee the reliability of the data and the respect of the information security, include: CRF design; preparation of the Data Management Plan; encoding of the medical terms by means of international dictionaries (MedDRA and WHO-DDE); management of inconsistencies emerged with the consistency check and plausibility of the collected data, database lock and data release for statistical analysis.

Regulatory & PharmacovigilanceGiuliana Palella2021-04-17T16:56:03+00:00

Regulatory & Pharmacovigilance

Management activities of the ethical-administrative authorization process for clinical studies.

Management of the requests for changes and clarifications by the Ethic Committee and Competent Authorities;
Compiling of the Clinical Trial Application (CTA) Form for the submission of the authorization request, and amendment;
Insertion of data in the OsSC- Osservatorio Nazionale per la Sperimentazione Clinica dei Medicinali and Observational Studies Register – RSO (opening and closing of the centres, conclusion of the study, insertion of the final results);
Activities to evaluate the safety profile of the drug in the study by collecting, monitoring and analysing the serious adverse events (SAE) and the SAE queries;
Management and reporting of suspected and unexpected serious adverse reactions (SUSAR) to Ethics Committees, Experts and Competent Authorities (through EudraVigilance);
Preparation and submission of the Development Safety Update Report (DSUR) to the Ethics Committees and competent authorities.

Development & NetworkingGiuliana Palella2021-04-17T16:56:03+00:00

Development & Networking

Development activities are aimed at the acquisition of national and international research projects and consist in:

seeking funding opportunities;
preparation of funding applications including writing, partner management, budget definition, etc.;
submission of applications and the overall management of application.

The networking activities are aimed to support the development activities and to favour the collaboration and interaction with many stakeholders, facilitating the transfer of the achieved know-how at different levels, leading to a strengthening of the scientific excellence promoting national and international research.

Communication & TrainingGiuliana Palella2021-04-17T16:56:03+00:00

Communication & Training

The resources operating in this area provide support in the:

Organization of events and meetings;
Preparation of informative materials (brochures, presentations, audio and video materials, leaflets);
Management of web mail services, web sites and social media;
Management of the on-line training courses;
Dissemination and communication of the project activities.

Quality AssuranceGiuliana Palella2021-04-17T16:56:03+00:00

Quality Assurance

The resources operating in this area provide support in the application and the improvement of the quality system. In particular, the QA has the following tasks:

Prepare and update the Quality Manual and the other SGQ documents, their release and diffusion;
Collaborate to define the necessary actions for the SGQ monitoring and improvement;
Verify the efficacy and the realization of the corrective and preventive actions;
Handle any audit for the suppliers (general and professional services);
Handle the control process on SGQ, planning the internal audits and keeping the records updated;
Record the training activities of the collaborators and store the documentation.

Moreover, he/she is responsible for:

Preparing the standard operating procedures in order to guarantee that the clinical studies conducted by CVBF as Sponsor or CRO are conducted and the data are recorded in compliance with the protocol and with the GCP;
Ensuring that the resources involved in the clinical studies are trained properly;
Performing controls through internal procedures or in collaboration with external professionals on the activities and the documents related to the clinical studies and checking whether the activities have been carried out properly, and the data have been recorded, analysed and communicated in compliance with the protocol, the SOPs and the GCP;
Performing controls during each phase of the data management in order to guarantee the reliability and the proper preparation of the data;
The Office Managers (OMs) in Bari and Pavia are part of the QA Area and have the following tasks:
Support the Direction for HR management and internal communication;
Manage offices assuring availability and maintenance of facilities, hardware and software, utilities and consumables;
Handle application and screening of CVs, planning interviews and providing feedback to the candidates;
Guarantee to all resources appropriate work space, documents and information on the organization and its rules;
Deal with all documentation related to the human resources, such as CVs, personal profiles, registries of presence;
Keep the HR calendar updated with absences, missions, training courses, conferences, etc. Handle the application and the screening of the CVs, planning interviews and providing the feedback to the candidates;

Informatio System (IS)Giuliana Palella2021-04-17T16:56:03+00:00

Informatio System (IS)

The resources operating in this area, have the following tasks:

Identify the technologies (hardware, software, infrastructure, communication) that respond to the informative and management needs of the organization;
Update periodically and suggest to the Direction a supplying plan of such technologies, In collaboration with the Project Managers and the Area Coordinators;
Define and manage the process of IS and the IT services supply (teleconferences facilities, internal data management system, email accounts, software and antiviruses, backups procedures, passwords, etc.;
Support Data Controller/Data Processors in guaranteeing data security and compliance with the applicable regulations;
Handle the issues related to web sites and IT resources and tools, in collaboration with the project managers and the Administrative and Communication & Training Areas;
Give advice on privacy issues and on the Data Protection Impact Assessment acting as Data Protection Officer (DPO).

Scientific AssistanceGiuliana Palella2021-04-17T16:56:04+00:00

Scientific Assistance

The resources operating in this area provide scientific support to all the activities carried out. In particular, the Scientific Assistant operates in strictly collaboration with the Scientific Director participating to:

the drafting of projects application;
the drafting, revision and management of the publications coming from the CVBF projects;
the preparation of scientific contents for the communication area;
the medical writing activities in the framework of clinical studies (protocol, IB, IMPD, clinical study reports, etc

AdministrationGiuliana Palella2021-04-17T16:56:04+00:00

Administration

The resources operating in this Area carry out the activities related to the project and the administrative management, and relate with the external consultants to ensure the fulfilment of the administrative and fiscal obligations. The main activities are:

Deal with the management of the funded projects and support the Project Managers;
Fill the reporting forms of the projects and store the support documentation;
Manage the qualification process of suppliers and verify purchase orders before submitting to the signature of the relevant functions (arrange purchase orders and deal with suppliers);
Handle the purchase processes, from the estimates acquisition to the proper execution of the supplies;
Perform cash checks, banks, and purchase / sales bills;
Deal with the receipts and payments;
Store the contract documents and the copy of the accounting, financial and administrative documents related to the clients and suppliers, personnel and collaborators, partners and reference institutions;
Directly manage or provide external consultants with all the data necessary for the upgrade of accounting records, the preparation of the financial fulfilments, as well as the revision activities;
Handle the mail, legal mail, protocol and archives.

Area CoordinatorGiuliana Palella2021-04-17T16:56:04+00:00

Area Coordinator

The Area Coordinator refers to the activities of his/her area of expertise and reports to the Direction on the qualification and development of resources. His/her tasks are:

support CVBF activities in his/her competence field towards external subjects and within the organization;
monitor the development of the activities within the area in terms of quality and quantity and suggest to the Direction the actions to solve any issue to foster the development;
deal with the professional improvement of HR in the area and submit the training plans to the Direction for approval;
suggest to the Direction a plan of renewal of working methodologies, goods and services for the activities of the Area.

CollaboratorGiuliana Palella2021-04-17T16:56:04+00:00

Collaborator

The collaborator participates to the activities of the projects for which he/she is appointed and respond to the Project Managers.

Project ManagerGiuliana Palella2021-04-17T16:56:04+00:00

Project Manager

The Project Manager ensures the respect of the timing and the results foreseen by the project, the production of the expected outputs and deliverables and the achievement of the technical-scientific objectives. The Project Manager guarantees the effective use of the resources, based on the budget of the project and the reference contract documentation. He/she reports to the Direction the progress and the achievement of the objectives, as well as the use of the resources and tools. The PM can be assisted by appointed administrative manager and collaborators for the project. In case of complex projects, further people can be identified as responsible for specific parts or work packages of the same project.

Identify the strategic lines for the proper conduction of the project;
Define the needs of the human resources (in terms of expertise and tasks), goods and services to be used for the project and submit the project budget to the Administrative Direction periodically
Plan the development phases of the project and its controls;
Monitor the activities of the team and provide the technical-methodological support;
Relate to the Reference Direction about the expertise of the resources in order to suggest some changes;
Delegate to the collaborators and any other appointed manager the execution of specific parts of the project;
Monitor reports and results of the project, defining needed actions for any issue during the progress of the project;
Interact with external referents identified for specific technical-scientific aspects of the project;
Submit to the approval of the Scientific Direction relevant project’s document (deliverables, publications, etc);
Submit to the approval of the Reference Direction the technical-scientific reports and any other documents, eventually along with the Scientific Direction approval.

Project DirectionGiuliana Palella2021-04-17T16:56:04+00:00

Project Direction

The Projects Director carries out activities necessary to promote the growth of the projects and services provided by CVBF. In particular, he/she has the following tasks:

Relate with the main CVBF partners and clients;
Coordinate the activities of the organization along with the Administrative Director and delegate to the Areas Coordinators the specific activities they are responsible for;
Define and appoint along with the Administrative Direction the team for each project, the roles, the responsibilities and the tasks of the team components, on the proposal of the Project Manager;
Approve the technical-scientific reports prepared under the Project Managers responsibility;

The Project Director is the Direction reference person for the following Areas: Quality Assurance, Information System, Regulatory & Pharmacovigilance, Trial Management & Monitoring, Research & Data Sharing.

Scientific DirectionGiuliana Palella2021-04-17T16:56:04+00:00

Scientific Direction

The Scientific Director is part of the CVBF Direction together with the Administrative Director and the Projects Director, and he/she is in charge of addressing the CVBF scientific activities, collaborating to the programme and scientific activities preparation, also through the coordination of the Scientific Committee tasks. The Scientific Director:

participate in meetings and congresses also in order to develop and maintain relationships with external strategic partners and stakeholders;
reviews and approves the technical-scientific outputs of CVBF activities and the scientific publications;
contributes with scientific inputs and contents to the development of new projects, since their submission to the concerned funding authorities or companies;
Prepares and reviews the annual research plans of the CVBF;
Suggests to the Board of Directors and the Assembly the programmatic lines for the development of the CVBF scientific activities..

Administrative DirectorGiuliana Palella2021-04-17T16:56:04+00:00

Administrative Director

The Administrative Director tasks are:

Supervise the accounting and financial management;
Approve the technical-administrative reports prepared under the Project Managers responsibility;
Coordinate the activities of the organization along with the Project Direction, delegate to the Area Coordinator the specific activities they are responsible for;
Define and appoint, along with the Project Direction, the team for each project, the roles, the responsibilities and the tasks of the team components, on the proposal of the appointed Project Manager.

The Administrative Direction is the direct responsible of the Areas: Administration, Communication and Training,
Development & Networking.

Chief Executive OfficerGiuliana Palella2021-04-17T16:56:04+00:00

Chief Executive Officer

The Chief Executive Officer (CEO) represents legally the CVBF, along with the President, and he/she is responsible of the legal, financial and administrative aspects, as well as of what foreseen in the Statute. His/ her tasks are:

- Deal with the preparation of the annual balance sheets, in collaboration with external consultants;

- Monitor the economic and financial needs and identify appropriate solutions;

- Negotiate and subscribe agreements of partnership and collaboration;

- Represent the Consortium towards Third Parties, subscribe contracts with clients and providers;

- Entrust tasks not otherwise contemplated in the corporate organization.

The CEO tasks are executed in all the Consortium sites in Italy and abroad.

Institutional Functions (General Assembly, Management Board, President, Chief Executive Officer)Giuliana Palella2021-04-17T16:56:04+00:00

Institutional Functions (General Assembly, Management Board, President, Chief Executive Officer)

The main tasks of the Institutional functions are regulated by the Statute of Consorzio per Valutazioni Biologiche e
Farmacologiche (CVBF).
The Institutional Organs supervise the operation of the Consortium, establishing the organizational structure and allocating
the resources (human, material, technological, financial resources) needed to reach the CVBF objectives.