European Medicines Agency - Regulatory - Regulation of medicines

5 -Training and educational capacity to build competencies



    Description

Name

 

MICYRN - Maternal Infant Child and Youth Research Network

Evidence of collaboration with regulatory authorities Yes MICYRN uses the service of a regulatory expert who has more than 20 years of expertise in regulatory (CTA) submission and knowledge of Health Canada processes and requirements. MICYRN is also involved in several advocacy efforts.
Capacity to provide competent consultation to regulatory authorities Yes MICYRN’s regulatory expert helps investigators in preparing meetings with Health Canada, developing and submitting Clinical Trial Applications.
Formal meetings for clinical trials Yes 1 trial (DOXA trial). MICYRN is the Canadian sponsor of this international trial. MICYRN organized several training sessions before and after activation of the participating sites.
Training courses given over the last 2 years No MICYRN partners with and supports IMPACT, a training program funded by CIHR. IMPACT: Increasing Capacity for Maternal and Paediatric Clinical Trials. Training courses and material are developed and administered by IMPACT.
Training courses received over the last 2 years No
Promotion of participation in clinical trials in countries with limited resources No
List of Countries