European Medicines Agency - Regulatory - Regulation of medicines

5 -Training and educational capacity to build competencies



    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