1125 The Fimp-Mcrn (Family Paediatricians Medicines for Children Research Network)

Abstract

Background and aims: The FIMP-MCRN, member of ENCePP (European Network of Centres of Pharmacoepidemiology and Pharmacovigilance), was established in 2003 with the aim of developing competence, infrastructure, networking and education for paediatric clinical trials.

It involves more than 6000 Italian Family Paediatricians (FPI) and it can survey more than 6.000.000 Italian children from 0 to 14 years.

It's on the point of becoming member of ENPREMA (European Network Paediatric Research at the EMA).

Methods: The FIMP - MCRN have developed and improved its expertise in Phase 3 and 4 clinical trials. It has got a Quality Control, a Quality Assurance and a traceability, a transparency and a data safety. Ad hoc training programs have incremented knowledge about clinical trials in FPI to build up the necessary competencies.

Results: A significant role can be played by the FPI with the participation to active pharmacovigilance projects. The primary objective of FIMP- Antibiotics Tolerability Profile Study (FIMP-ATPS) was to assess in patients with pharyngotonsillitis (FT) and rhinosinusitis (RS) the antibiotic tolerability profile after the days of administration.

A different, more proactive, approach is needed to use of disease databases[ FIMP-Dumbo Othitis Study (more than 400 children included)] and FPISentinel Influence A (H1N1) Survey [including possible ADRs after vaccination]. In epiweek 45 the incidence of H1N1 was 28,19 (0-4 yr) and 40.78 (5- 14 yr) cases per 1.000.

Conclusions: Networking is mandatory to build up the necessary competencies, to facilitate cooperation, to share the skills and expertise and to avoid duplication of studies.

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