European Medicines Agency - Regulatory - Regulation of medicines

3 - Specific competencies and capacity to provide export advice



    Description

Name

 

FP-MCRN - Family Pediatricians Medicines for Children Research Network

Number of peer reviewed publications in the last 5 years 5 1 ) Napoleone E, Scasserra C “ADRs and Children : the correct use of drugs in pediatrics” International Journal of Scientific Research 2018, (7) 563- 564 2 ) Napoleone E., Lavalle A. and Scasserra C. “Antimicrobial Stewardship in Pediatrics. Training, Prescribing and Surveillance: An Initiative in Outpatient Children.” EC Pharmacology and Toxicology 2018. 6(4): 268-276. 3 ) Lavalle A,.Gentile S, Napoleone E., Ricci M.. Lo studio dell’inappropriatezza prescrittiva degli antibiotici in pediatria nella Regione Molise e l’efficacia dei risultati per la governance della spesa farmaceutica Mondo Sanitario 2018. 9: 1-9. 4) Napoleone E., Lavalle A., Scasserra C., Ricci M. Surveillance of Inhaled Steroids (IS) in children :the REDS (Respiratory Drugs Survey) Study. in Pediatrics, E. (2018). 10th Excellence in Pediatrics Conference—2018 Book of Abstracts. Cogent Medicine, 5(1), 1544190. https://doi.org/10.1080/2331205X.2018.1544190 5) E. Napoleone, A. Lavalle, C. Scasserra, M. Rossi, G. Bucaneve, R. E. Rocchi and M. Ricci REDS (Respiratory Drugs Survey) Study. Active Surveillance of Respiratory Drugs and in Particular of Inhaled Steroids (IS) in the Paediatric Age International Journal of Pediatrics and Child Health, 2018, 6, 27-41
Number of competitive grants obtained in the last 5 years 0 In all the publications there is the contribution of FP-MCRN. The REDS (Respiratory Drugs Survey) Study, Active Surveillance of Respiratory Drugs and in Particular of Inhaled Steroids (IS) in the Paediatric Age, was awarded with ENCEPP STUDY SEAL, having passed the indipendence,the scientific standards and the transparency criteria.
Access to expert groups Yes Many pediatricians take part of Learned Society like SIMPe or SIP
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 GCP and Ethical Consideratins
Participant recruitment Yes
Budget calculation for studies No