European Medicines Agency - Regulatory - Regulation of medicines

5 -Training and educational capacity to build competencies



    Description

Name

 

TREAT-NMD - Neuromuscular Network

Evidence of collaboration with regulatory authorities Yes TREAT-NMD has since its inception worked closely with regulators including the EMA. Several workshops have been held at and organised with the EMA. Most recently a workshop was organised by SMA and EMA, entitled "EMA Workshop - Development of Therapies for the Treatment of Spinal Muscular Atrophy" in November 2016. Similar workshops focusing on Duchenne muscular dystrophy have been organised previously.
Capacity to provide competent consultation to regulatory authorities Yes Both Members of the Steering Committee as well as the Secretariat serve on standing scientific committees including the Interdisciplinary Scientific Committee of the International Rare Diseases Research Consortium (IRDiRC) and the World Muscle Society.TREAT-NMD has organised several meetings hosted by and at the EMA, focusing on DMD and SMA.
Formal meetings for clinical trials No
Training courses given over the last 2 years Yes TREAT-NMD has organised 2 NMD-focussed Masterclasses in the last two years. Please find links to reports about the Masterclasses: http://www.treat-nmd.eu/events/653/ and http://www.treat-nmd.eu/newsletter/archive/email/31st_May_2017.html
Training courses received over the last 2 years No
Promotion of participation in clinical trials in countries with limited resources No
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