5 -Training and educational capacity to build competencies
Quality
Management |
Training and
Education |
Public
Involvement |
Description | ||
---|---|---|
Name |
PIBD-Net - Pediatric Inflammatory Diseases Network |
|
Evidence of collaboration with regulatory authorities | Yes | PIBD-Net members are key academics in their countries participating for guidelines of regulatory authorities through national learned societies Furthermore, the board members of PIBD-Net have a longstanding interaction with the EMA and the FDA. |
Capacity to provide competent consultation to regulatory authorities | Yes | PIBD Net members are key academics in their countries participating for guidelines of regulatory authorities through national learned societies |
Formal meetings for clinical trials | Yes | Each month, for each study, a conference call is scheduled with the PIs and their clinical team to discuss about the study progress and make a training on one specific GCP point. |
Training courses given over the last 2 years | Yes | During each site initiation, PIBD-Net project manager trains the site participants to the study procedures and to the GCP in accordance with the PIBD-Net SOPs. |
Training courses received over the last 2 years | No | |
Promotion of participation in clinical trials in countries with limited resources | Yes | PIBD-Net has members in all European countries, several Eastern European countries have only limited research resources, as do have several south American and Asian countries, active collaborations are underway allowing these countries to participate. |
List of Countries |