5 -Training and educational capacity to build competencies
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
ECAPN - European Child & Adolescent Psychopharmacology Network |
|
| Evidence of collaboration with regulatory authorities | Yes | Members of the network are regularly consulted by EMA and National Authorities for paediatric CNS medications; They apply to EMA for Paediatric Investigation Plans (PIPs) for specific Academic Studies/ projects. EMA is also involved in a recent project aimed at an update of unmet needs in paediatric psychopharmacology. |
| Capacity to provide competent consultation to regulatory authorities | Yes | Members of the network are regularly consulted by EMA and National Authorities for paediatric CNS medications; They apply to EMA for Paediatric Investigation Plans (PIPs) for specific Academic Studies/ projects. EMA is also involved in a recent project aimed at an update of unmet needs in paediatric psychopharmacology. |
| Formal meetings for clinical trials | Yes | 6 to 8 a year |
| Training courses given over the last 2 years | Yes | ECNP School on Child & Adolescent Neuropsychopharmacology: https://www.ecnp.eu/about-ecnp/history/past-ecnp-meetings/past-schools.aspx) - National Training Programs - Training Programs , including GCP, for specific projects including GCP for specific sponsored clinical trials. |
| Training courses received over the last 2 years | Yes | ECNP School on Child & Adolescent Neuropsychopharmacology: https://www.ecnp.eu/about-ecnp/history/past-ecnp-meetings/past-schools.aspx) - National Training Programs - Training Programs , including GCP, for specific projects including GCP for specific sponsored clinical trials. |
| Promotion of participation in clinical trials in countries with limited resources | Yes | Countries with limited resources have been involved in academic studies and suggested to Company CROs |
| List of Countries |