European Medicines Agency - Regulatory - Regulation of medicines

D - Description



  Description

Name

FP-MCRN - Family Pediatricians Medicines for Children Research Network)

Year of foundation The FP-MCRN ONLUS was established in 2015 with the aim of developing competence, infrastructure, networking and education for paediatric clinical trials. Since 2003, the year FP-MCRN was founded, 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. Of the network, or of the investigator’s or site’s specific paediatric research activities
Preterm and/or term newborn Yes
Infants from 1 month to less than 24 months of age Yes
Children from 2 years to less than 12 years of age Yes
Adolescents from 12 years to less than 18 years Yes
Paediatric age ranges of study participants covered by the network 0-16 years
Multispeciality? Specify allergology,clinical pharmacology,dermatlogy,nutrition, epidemiology,public health,gastroenterology, primary pediatrics.infectious diseases,vaccinology,pediatric rehabilitation,Pharmacovigilance,,
Speciality/disease specific? Specify
Conditions covered? Specify Asthma
Procedure/Intervention specific? Specify
Number of collaborating countries 1
List of collaborating countries
Number of collaborating centres 3
List of collaborating centres Regional Pharmacovigilance Center -Molise Regional Pharmacovigilance Center -Umbria Regional Pharmacovigilance Center -Emilia Romagn
Type of activity/studies Efficacy and PASS
Clinical Studies Yes
Experimental research
Other activity Training and educational in clinical studies (Pediatricians and Families)