5 -Training and educational capacity to build competencies
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
PRINTO - Pediatric Rheumatology International Trials Organisation |
|
| Evidence of collaboration with regulatory authorities | Yes | EMA GUIDELINE ON CLINICAL INVESTIGATION OF MEDICINAL PRODUCTS FOR THE TREATMENT OF JUVENILE IDIOPATHIC ARTHRITIS |
| Capacity to provide competent consultation to regulatory authorities | Yes | EMA required our assistance for some trials |
| Formal meetings for clinical trials | Yes | For each pharma company-sponsored trial there is at least one dedicated investigators meeting. For academic studies meeting are done annually at the PRES conference where a PRINTO workshop is always held |
| Training courses given over the last 2 years | Yes | At each investigator meeting PRINTO provides some training (e.g. joint assessment procedures, evaluation of response to therapy) |
| Training courses received over the last 2 years | Yes | participation to investigator's meeting and scientific meetings |
| Promotion of participation in clinical trials in countries with limited resources | Yes | Latin and Central America, Eastern Europe, India |
| List of Countries |