European Medicines Agency - Regulatory - Regulation of medicines

5 -Training and educational capacity to build competencies



    Description

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eYPAGnet - European Young Persons Advisory Groups Network

Evidence of collaboration with regulatory authorities Yes All founding members are involved in managing clinical trials to GCP standards and are GCP certified.
Capacity to provide competent consultation to regulatory authorities Yes Patient input provided to European Regulation, chapter of Ethics. Survey provided by EMA related to palatability and research participation Participation in Better Medicines for Children workshop at EMA 2016 At national level, assent guidelines for pediatric clinical trials (AEMPS; Spain , page 9 https://www.aemps.gob.es/investigacionClinica/medicamentos/docs/anexo7-Ins-AEMPS-EC.pdf )
Formal meetings for clinical trials Yes Patient's input porvided to the reseracher after the revision of a clinical trial
Training courses given over the last 2 years Yes All YPAGs provide training to their members. The training includes clinical trial design, research governance and drug development. The training programme will be developed and standardised across the network.
Training courses received over the last 2 years Yes ICAN summit annual worlwide meeting attended by representatives on behalf of all European groups
Promotion of participation in clinical trials in countries with limited resources
List of Countries