5 -Training and educational capacity to build competencies
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
EPLTN - European Paediatric Liver Transplantation Network |
|
| Evidence of collaboration with regulatory authorities | Yes | For the current study, regulatory authoroties other than the local ethic advisory boards are not involved. For future studies, the following network members have extensive experience in collaborating with regulatory authorities: Birmingham: MHRA (Medicines and Healthcare products Regulatory Agency, UK) |
| Capacity to provide competent consultation to regulatory authorities | Yes | see 5.1. |
| Formal meetings for clinical trials | Yes | 4-5/year for current trial (planning meetings for PIs, progress meetings for PIs and site staff) |
| Training courses given over the last 2 years | Yes | |
| Training courses received over the last 2 years | Yes | Network members have received training courses regarding ICH GCP, clinical trial conductance and project management for clinical trials. In addition, selected members have participated in trial specific trainings for a range of industry sponsored trials. |
| Promotion of participation in clinical trials in countries with limited resources | Yes | |
| List of Countries | Afric + Asien Countries |