5 -Training and educational capacity to build competencies
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
PCIC - Pediatric Clinical Investigation Center, Belgium |
|
| Evidence of collaboration with regulatory authorities | Yes | Regular meetings with Belgian Regulatory authorities (AFMPS). All protocols involving investigational products have regulatory approval from AFMPS. |
| Capacity to provide competent consultation to regulatory authorities | Yes | Our center has the expertise in paediatric gastroeneterology and hepatology and also metabolic disease (orphan disease ) to provide competent consultation to regulatory authorities if required |
| Formal meetings for clinical trials | No | |
| Training courses given over the last 2 years | No | |
| Training courses received over the last 2 years | Yes | Several training courses have been followed by our staf, mostly related to studies but alsoin regulatory affairs, paediatric clinicals trial, GCP, IATA, monitoring of the clinical research. |
| Promotion of participation in clinical trials in countries with limited resources | No | |
| List of Countries |