5 -Training and educational capacity to build competencies
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
ECFS-CTN - European Cystic Fibrosis Society - Clinical Trials Network |
|
| Evidence of collaboration with regulatory authorities | Yes | ECFS-CTN is in discussion with EMA regarding the specific guidelines for cystic fibrosis clinical trials (workshop on endpoints for cystic fibrosis clinical trials European Medicines Agency, London, 27-28 September 2012) http://www.ema.europa.eu/docs/en_GB/document_library/Report/2012/12/WC500136159.pdf A similar workshop was conducted 08Dec2015 to discuss gastrointestinal endpoints http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/events/2015/11/event_detail_001241.jsp&mid=WC0b01ac058004d5c3 |
| Capacity to provide competent consultation to regulatory authorities | Yes | see above |
| Formal meetings for clinical trials | No | 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) |
| Training courses received over the last 2 years | Yes | idem as above |
| Promotion of participation in clinical trials in countries with limited resources | No | |
| List of Countries |