European Medicines Agency - Regulatory - Regulation of medicines

2 - Network organisation and process



    Description

Name

 

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

Existence of an identified contact person for external enquiries Yes All external enquires (from patients,parents,organisation, researchers,pharmaceutical commpanies , regulatory authorities) are coordinated by Dr.Ettore Napoleone ,President of FP-MCRN). Dr.Napoleone is past member of AIFA(Italian Drug Agency) Paediatric Working Group and member of ASREM Ethics Committee
Existence of an internal steering committee Yes Steering Committee inside the FP-MCRN, formed by family paediatricians who have the best competence and experience. The Steering Committee, with the responsibility and supervision of the President of FP-MCRN, will have the task of proposing research projects, regular reviewing, organising training courses, epidemiological investigating, attending to internationalconferences, magazine publishing with IF and everything which has to do with science and that will be considered useful for family paediatricians’ clinical research. Moreover, the Steering Committee will control, verify and implement all the scientific activities proposed and/or suggested by each member of the RWG. Finally, the Steering Committee will have the task to verify the methodological quality of all the research projects which will then be evaluated by Ethics Committees.
Existence of an external advisory steering committee directing the reporting party No
Existence of a website Yes http://www.pmrnet.org/en/
Existence of newsletter Yes Newsletter are distributed actively both on website and on surface mail to unclosed recipients
Existence of internal databases for disease, condition treatment and/or outcome Yes FP-MCRN capacity to recruit patients is very high.
Provisions to ascertain data protection and data security Yes
Procedures to access the database by third parties No
Access to external databases/registries No
Standardised process to access an external database No