European Medicines Agency - Regulatory - Regulation of medicines

5 -Training and educational capacity to build competencies



    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