5 -Training and educational capacity to build competencies
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
BPCRN - Belgian Pediatric Clinical Research Network |
|
| Evidence of collaboration with regulatory authorities | Yes | We implement all national guidelines and have contacts with the competent authority (FAGG) |
| Capacity to provide competent consultation to regulatory authorities | Yes | |
| Formal meetings for clinical trials | Yes | SIVs, investigator meetings, together with the sponsor upon requests. |
| Training courses given over the last 2 years | Yes | We ensure that all BPCRN members are GCP trained on a regular basis. We provide access for our members to conect4children Academy trainings (accredited pediatric GCP and refresher courses, advanced course on pediatric clinical trials,...). |
| Training courses received over the last 2 years | Yes | In the last 4y, over 100 participants took part in more than 20 courses (together enrolling more than 250 times). These include trainings in Advanced course on Paediatric Clinical Trials and Paediatric Drug Development, An introduction to innovative clinical trial design, Audit and Inspection Readiness, c4c IS training, Developmental pharmacology, Elements of Clinical Trials Methodologies, Ethics Committee evaluation of a paediatric clinical trial, GCP and GCP Refresher Course, Institutional Readiness for Gene Therapy, Involving children and young patients and families' in designing clinical Research, Paediatric Investigation Plans, Registries in Paediatric Drug Development, Remote and Hybrid Paediatric Clinical Trials, The process to obtain the Informed Consent and Assent, The Role of Research Nurses in Paediatric Clinical Trials, Train-the-Trainer, Trial Monitoring, and Trial Start Up |
| Promotion of participation in clinical trials in countries with limited resources | No | |
| List of Countries |