5 -Training and educational capacity to build competencies
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
NorPedMed - Medicines for Children Network Norway (Department of Pediatrics, Haukeland University Hospital) Norway |
|
| Evidence of collaboration with regulatory authorities | Yes | NorPedMed reports directly to the Norwegian Directory of Health, through its "mother organisation" Medicines for Children Network, Norway. Thus, NorPedMed plays an active part in the work of relevant regulatory institutions, implementation of guidelines etc. |
| Capacity to provide competent consultation to regulatory authorities | Yes | The NorPedMed representatives at the clinical trial units at the university hospitals are senior consultants with competence to provide expert advice to regulatory authorities. |
| Formal meetings for clinical trials | Yes | A kick-off seminar for all involved parties in 2014, and after that annual meetings. Monthly telephone conferences and regular meetings between the responsible pediatricians at the participating clinical trial units |
| Training courses given over the last 2 years | Yes | NorPedMed is actively participating in GCP courses provided by university hospitals in Norway, lecturing both medical students and relevant health professionals. |
| Training courses received over the last 2 years | Yes | Training courses have been received by several members of NorPedMed in relation to a number of clinical trials during the last two years, the exact figures can't be reproduced. |
| Promotion of participation in clinical trials in countries with limited resources | No | |
| List of Countries |