5 -Training and educational capacity to build competencies
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
FP-MCRN - Family Pediatricians Medicines for Children Research Network) |
|
| Evidence of collaboration with regulatory authorities | Yes | Dr Ettore Napoleone was member of PWG -AIFA.PWG was formed with the aim to create continuity between the world of pediatrics and Regulatory activity both Italian and international level (EMA). PWG was formed, with the collaboration of many experts, with a specified aim and that is to launch initiatives and measures for more rational use of the drug in children. FP (AIFA-PWG) contributed to regulatory activities with a critical revision of the benefit/risk profile of some relevant paediatric drugs (e.g. sympathomimetic nasal decongestants banned below 12aa, metocloparamide prohibited below 16aa, recommendations on tropicamide and phenylephrine , domperidone and oxatomide).A systematic analysis was conducted off-label use of medicines for children.It 'was drawn up an updated list of off-label drugs associated with the availability of scientific evidence 29 off-label drugs that are necessary to treat cardiovascular pathologies in children are legitimized by the PWGAIFA. Thus, their use is authorized and they can be supplied by the National Health Service. Such drugs belong to the following classes: antiarrthymics, calcium antagonists, hypocholesterolemics, hypotensives, peripheral vessel dilators, ACEinhibitors, beta-blockers, diuretics and sympathicomimetics. |
| Capacity to provide competent consultation to regulatory authorities | Yes | Dr.Napoleone was nominated Assessor by AIFA for Rapporteur's Preliminary Assessment Report for paediatric studies submitted in accordance with Article 46 of Regulation (EC) n° 191/2006,as amented ENTEROGERMINA® / NORMAFLORE® Bacillus clausii multiantibioresistant spores |
| Formal meetings for clinical trials | Yes | 2. 3 Investigator's meeting were organised for clinical trials For example, investigator meetings, trainings specific to a given ongoing or planned trial. |
| Training courses given over the last 2 years | Yes | Training courses given over the last 2 years were 3: a) N.1 BASIC Family Paediatricians -Investigators Course b) n.2 ADVANCED Clinical Research Master |
| Training courses received over the last 2 years | Yes | Training courses received : 2 (Investigator's meeting ) |
| Promotion of participation in clinical trials in countries with limited resources | No | |
| List of Countries |