3 - Specific competencies and capacity to provide export advice
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Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
FP-MCRN - Family Pediatricians Medicines for Children Research Network) |
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| Number of peer reviewed publications in the last 5 years | 11 | 1)-E. Napoleone “ Children and ADRs (Adverse Drug Reactions) “ Ital J Pediatr 2010 Jan 15, 36:4 PMID: 20180963 [PubMed - indexed for MEDLINE] 2)Ettore Napoleone and Giuseppe Mele The FIMP- Medicines for Children Research Network Ital J Pediatr. 2010 Jun 30;36(1):46. PMID: 20591168 [PubMed - as supplied by publisher] 3) E. Napoleone, G.Mele “Medicines for children : the proactive approach of the FIMP-MCRN ( Family Paediatricians - Medicines for Children Research Network) ” ACTA PEDIATRICA. 2010; Volume 99, Issue Supplement s462, p.113 4) E. Napoleone, G.Mele “The FIMP-MCRN ( Family Paediatricians - Medicines for Children Research Network) ” Pediatric Research: November 2010 - Volume - Issue - ppg 557 5)E. Napoleone “ Excellence in Family Paediatricians: the FIMP-MRCN (Medicines for Children Research Network) becomes a member of ENPR-EMA ( European Network of Paediatric Research at the European Medicines Agency)“ Ital J Pediatr 2011 Jan 19, 37:7 PMID: 21247483 [PubMed - indexed for MEDLINE] 6) E. Napoleone “The FIMP-MCRN ( Family Paediatricians - Medicines for Children Research Network) :generating evidence and safety at the point of care” Evid.-Based Child Health .2011.6 (suppl.1). 37 7)Napoleone E, Radice S. From pharmacovigilance to therapy amelioration in paediatric patients: The role of the clinical pharmacologists and family paediatricians Part of a series on Paediatric Pharmacology, guest edited by Gianvincenzo Zuccotti, Emilio Clementi, and Massimo Molteni. Pharmacol Res. 2011 Sep 10. [Epub ahead of print ]PMID: 21983004 [PubMed - as supplied by publisher] 8) Bottaro G, Biasci P, Lo Giudice M, Mele G, Montanari G, Napoleone E, Santucci A, Tucci PL, Fano M, Biraghi MG. 5 days Cefaclor vs. 10 days amoxicillin/clavulanate in the treatment of childhood streptococcal pharyngitis. Data from a randomized clinical trial. Minerva Pediatr. 2012 Jun;64(3):341-6. Italian. PMID: 22555328 [PubMed - indexed for MEDLINE] 9)Pellegrino P.; Carnovale C, Cattaneo D, Perrone V ,Antoniazzi S, Pozzi M, Napoleone E, Filograna MR, Clementi E, Radice S Pharmacovigilance knowledge in family paediatricians. A survey study in Italy. Health Policy 10)Napoleone e. ,Scasserra C.,Pharmacovigilance in pediatric age:the role of Family pediatricians-Medicines for Children Research Network (FP-MCRN) .JPharmacovigilance 2015.3.168; 11) Napoleone E.,Lavalle A.,Scasserra C., Ricci M., Active surveillance on the use of the antibiotics in children , particularly in the age group from 0 to 2 years, J.Pharmacovigilance,2016,4.2 |
| Number of competitive grants obtained in the last 5 years | 2 | Family Paediatricians have participated to various clinical studies and research projects in collaboration with the most important national Universities and/or Research Institutes This has allowed them to acquire experience and rigorous methodology in clinical paediatrics research. Despite the fact that in the opening phases, Family Paediatrician involvement in clinical trials was quite poor throughout the Italian territory, from 2008 a national organisation has created the characteristics for a fully independent scientific running of clinical trials (n. 11 independent publications) |
| Access to expert groups | Yes | |
| Capacity to answer external scientific questions | Yes | |
| Site feasibility | Yes | Family Paediatricians can carry out phase three and four of clinical studies according to the Ministerial Decree 139/2001 which states that clinical trials can be carried out in all those ambulatories, of both single and/or associate doctors, which have all the characteristics (logistics, instrumentations, etc.) in accordance with the protocol of studies and the principles of ICH-GCP; |
| Participant recruitment | Yes | |
| Budget calculation for studies | No |