5 -Training and educational capacity to build competencies
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
PENTA- ID - Paediatric European Network for the Treatment of AIDS and Infectious Diseases |
|
| Evidence of collaboration with regulatory authorities | Yes | All protocols involving investigational products have regulatory approval; procedures are in place for compliance - periodic and expedited safety reporting, |
| Capacity to provide competent consultation to regulatory authorities | Yes | Members of the PENTA-ID Steering Committee are advisory members on the EMA PDCO and national advisory committees for all antimicrobials |
| Formal meetings for clinical trials | Yes | Meetings at all levels: site, regional, national and international |
| Training courses given over the last 2 years | Yes | Site + trial specific training given as well by country; also training courses organised for health care workers (see pentatrials.org/training.htm) |
| Training courses received over the last 2 years | Yes | All staff have updates in GCP and regulatory issues |
| Promotion of participation in clinical trials in countries with limited resources | Yes | PENTA-ID has always tried to increase recruitment into clinical trials from countries with limited resources. |
| List of Countries | Argentina, Brazil, Thailand, Uganda, Russia, Ukraine |