European Medicines Agency - Regulatory - Regulation of medicines

3 - Specific competencies and capacity to provide export advice

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TEDDY - European Network of Excellence for Paediatric Research
Number of peer reviewed publications in the last 5 years 18 2024 • Felisi M, Bonifazi F, Toma M, Pansieri C, Leary R, Hedley V, Cornet R, Reggiardo G, Landi A, D’Ercole A, Malik S, Nally S, Sen A, Palmeri A, Bonifazi D, Ceci A Mapping of Data-Sharing Repositories for Paediatric Clinical Research—A Rapid Review Data 2024, 9, 59. https://doi.org/10.3390/data9040059 • Suchkov S, Scherman D, Bonifazi D, Antonova E, Murphy S, Flaks G, Dunning T, Smith D , Abe H Personalized and Precision Medicine (Ppm) As a Unique Healthcare Model of the Next Step Generation: The Role of a Nurses and Nursing Practice in Transdisciplinary Care Team: The Future of Nursing Services. Journal of Biomedical and Engineering Research 2024,Volume 2, Issue 1. 2023 • Healy P, Verrest L, Felisi M, Ceci A, Della Pasqua O, GAPP Consortium Dose rationale for gabapentin and tramadol in pediatric patients with chronic pain British Pharmacology Society Journals, 06 October 2023, DOI: 10.1002/prp2.1138 • Giannuzzi V, Ruggieri L, Conte R, Manfredi C, Felisi MG, Kubiak C, Matei M, Malik S, Demotes J, Ceci A, Bonifazi D PedCRIN tool for the biosamples management in pediatric clinical trials. Clin Transl Sci. 2023 May;16(5):797-809. doi: 10.1111/cts.13489. Epub 2023 Feb 19. • 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 - 2023 | https://doi.org/10.3389/fneur.2023.1163855 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 • Sen A, Hedley V, Owen J, Cornet R, Kalra D, Engel C, Palmeri A, Lee J, Roze J.C, Standing J, Warris A, Pansieri C, Leary R, Turner M, Straub V Standardizing Paediatric Clinical Data: The Development of the conect4children (c4c) Cross Cutting Paediatric Data Dictionary Journal of the Society for Clinical Data Management. 2022; 2(3): 4, pp. 1–10. 2021 • 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 • 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 • 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 • 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 • T.G. de Leeuw, T. van der Zanden, S. Ravera, M. Felisi, D. Bonifazi, D. Tibboel, A. Ceci, F. Kaguelidou, S. N. de Wildt; 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. • 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 • 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: 10.1136/bmjpo-2020-000847 • Altavilla A, Giannuzzi A, Lupo M, Bonifazi D, Ceci A. Ethical, Legal and Regulatory Issues of Paediatric Translational Research. Call for an Adequate Model of Governance. European Journal of Health Law. May 2020. 1–19. Available at: https://brill.com/view/journals/ejhl/27/3/article-p213_3.xml • Gini R, Sturkenboom MC, Sultana J, Cave A, Landi A, Pacurariu A, Roberto G, Schink T, Candore G, Slattery J, Trifirò G; Working Group 3 of ENCePP. Different strategies to execute multi‐database studies for medicines surveillance in real world setting: a reflection on the European model. Clin Pharmacol Ther. 2020 Apr 3. doi: 10.1002/cpt.1833
Number of competitive grants obtained in the last 5 years 5 Listed publications have been either performed on behalf of the Network or derived by TEDDY activities
Access to expert groups Yes TEDDY has access to expert groups directly within the Network, covering a wide range of pediatric medical disciplines. Furthermore, it benefits from its involvement in other networks, including EPTRI, INCiPiT, and ENCePP
Capacity to answer external scientific questions Yes Through collaboration, advocacy, and education, TEDDY seeks to transform the way children’s health is managed, always keeping the best interests of the child at the heart of our work. • European Paediatric Medicines Database:Managing the EMPD which allows monitoring of the status of art of paediatric medicines approved by the EMA. • Off label uses mitigation: Plan of action to reduce the off label use of drugs in children using good practices, SOPs and tools developed by TEDDY and other research groups in Europe. • Paediatric Research Methodologies: Methodologies for conducting paediatric studies and clinical research in the paediatric population. • Pharmacoepidemiology and Pharmacovigilance: Contributing to the European Network of Centers for Pharmacology and Pharmacovigilance (ENCePP) in which TEDDY is responsible for the pediatric aspects. • Children empowerment and engagement: engaging young people in decisions related to their health and enhancing awareness among stakeholders. Young Person Advisory Groups (YPAGs) created by TEDDY. People with expertise in the relevant listed fields work on the planned activities. The work plans are structured and external parties can request information via the contact page of the website and survey, and address specific requests.
Site feasibility Yes Assessed case by case on the basis of SOPs and standards selected and approved by the Network.
Participant recruitment Yes The Network is able to achieve a wide recruitment in multinational clinical trials and it can also ensure the participation of third countries in some therapeutic areas.
Budget calculation for studies Yes The Network regularly provides budget calculations for clinical trials and agreements, including partition site by site.