5 -Training and educational capacity to build competencies
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
Pedmed-NL - Medicines for Children Research Network Netherlands |
|
| Evidence of collaboration with regulatory authorities | Yes | Presentations (invited) to both Dutch Regulator (CBG) and EMA PDCO |
| Capacity to provide competent consultation to regulatory authorities | Yes | Several national network members are members of similar committees. We became a member of the platform of research networks of the Dutch Clinical Research Foundation |
| Formal meetings for clinical trials | Yes | Site selection, SIVs and follow-up meetings organized in collaboration with sponsor upon request |
| Training courses given over the last 2 years | Yes | through C4c, training courses are offered to our network partners. Dutch participation has been high. pedmed staff has been involved in development of training materials for C4c During regular network meetings, training is provided by members of the network to participants. Dutch Pediatric Society research Day (2022, 2024): training on the use of networks for research and how to work with CROs as site |
| Training courses received over the last 2 years | Yes | - GCP - IMP supply - Involving Children and Young Patients and Families' in Designing Clinical Research - Issues Experienced in Neonatal Clinical Trials - The Role of Research Nurses in Paediatric Clinical Trials (offered by c4c academy) |
| Promotion of participation in clinical trials in countries with limited resources | No | N/A |
| List of Countries |