European Medicines Agency - Regulatory - Regulation of medicines

5 -Training and educational capacity to build competencies

    Description

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ECFS-CTN - European Cystic Fibrosis Society - Clinical Trials Network
Evidence of collaboration with regulatory authorities Yes Between 2020 and 2024, ECFS had the following collaborations with EMA: 2020-2024: participation at annual Enpr-EMA meeting 2023: HIT-CF consortium (of which ECFS-CTN is a partner) achieve letter of support for Forskolin-Induced Swelling (FIS) assay as a novel methodology 2023: ECFS provides response to EMA consultation on guidance about single arm trials. 2023: ECFS-CTN provided input to the Public consultation on ACT EU multistakeholder platform (ACT EU MSP) participation and priorities for discussion 2024: ECFS-CTN responds to an Enpr-EMA query about clinical trial outcome measures in young children with CF
Capacity to provide competent consultation to regulatory authorities Yes We capacity for this, and actively provide input to EMA open consultations and to specific queries.
Formal meetings for clinical trials Yes Most are organized by the pharma company or academic sponsor.
Training courses given over the last 2 years Yes 5 (yearly training day for ECFS-CTN investigators and research coordinators, at the ECFS conference in June + ad hoc onlin e webinars)
Training courses received over the last 2 years Yes idem as above
Promotion of participation in clinical trials in countries with limited resources Yes Our network includes several sites from upper middle income countries (UMIC) (Hungary, Poland). ECFS-CTN sites act as mentors in the ECFS/CFE Twinning project, where expert centres twin with other centres wishing to improve care. The mentee sites are in countries with limited resources. This programme aims to improve care, rather than clinical trials. However, optimising care is a critical first step before participating in clinical trials. https://www.ecfs.eu/ecfs-standards-care/twinning
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