5 -Training and educational capacity to build competencies
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
OKIDS - Medicines for Children Research Organization Austria |
|
| Evidence of collaboration with regulatory authorities | Yes | regular OKIDS advisory board meetings (reference at www.okids-net.at) including presence of the competent regulatory authority of Austria (AGES) |
| Capacity to provide competent consultation to regulatory authorities | Yes | The membes of the OKIDS steering committee all have profound academic carrers and can be consulted in the respective expert aereas on request. The latter happens in fact alraedy on a regular bases as members of the OKIDS steering committee are sitting in advisory function in respective relevant panels established by authorities ( i.e. PDCO, Oncology Advisory Board of the Ministry of Health, etc...) |
| Formal meetings for clinical trials | Yes | The local sites of OKIDS harbour experts in the field being responsible of academic clinical trials. In OKIDS support function such activities are assisted by OKISD on request |
| Training courses given over the last 2 years | Yes | All the OKIDS sites at the universities and reserach institues offer GCP training in clinical trials to personnel on a regular level and are accessible at least once a year at each site for study personell , i.e. Salzburg/Dr. Lagler: 12 training courses in the last 2 years Innsbruck/Mag. Sabine-Embacher: 13 training courses in the last 2 years Graz/Mag. Pfaffenthaler: 12 training courses in the last 2 years |
| Training courses received over the last 2 years | Yes | Site study teams and staff have received external training in 21 trials running in Austria with OKIDS involvement for principle investigators and study teams within the scope of industry driven trials |
| Promotion of participation in clinical trials in countries with limited resources | No | OKIDS activities are restricted to Austria |
| List of Countries |