European Medicines Agency - Regulatory - Regulation of medicines

5 -Training and educational capacity to build competencies



    Description

Name

 

ECAPN - European Child & Adolescent Psychopharmacology Network

Evidence of collaboration with regulatory authorities Yes Members of the network are regularly consulted by EMA and National Authorities for paediatric CNS medications; They apply to EMA for Paediatric Investigation Plans (PIPs) for specific Academic Studies/ projects.
Capacity to provide competent consultation to regulatory authorities Yes Members of the network (and the Network itself via ECNP) are regularly consulted by EMA and National Authorities for paediatric CNS medications; many of them have served as external experts for National Regulatory Authorities (UK-Scotland, France, Italy, Spain)
Formal meetings for clinical trials Yes 6-8 per year
Training courses given over the last 2 years Yes ECNP School on Child & Adolescent Neuropsychopharmacology: https://www.ecnp.eu/about-ecnp/history/past-ecnp-meetings/past-schools.aspx) - National Training Programs - Training Programs , including GCP, for specific projects PERS, ADDUCE, STOP, EMTICS, TICS GENETICS, MATRICS Training, including GCP,for specific sponsored clinical trials.
Training courses received over the last 2 years Yes ECNP School on Child & Adolescent Neuropsychopharmacology: https://www.ecnp.eu/about-ecnp/history/past-ecnp-meetings/past-schools.aspx) - National Training Programs - Training Programs , including GCP, for specific projects PERS, ADDUCE, STOP, EMTICS, TICS GENETICS
Promotion of participation in clinical trials in countries with limited resources Yes countries with limited resources have been involved in academic studies and suggested to Company CROs
List of Countries  

Hungary, specific centres involved in their studies China and Brasil