EMA publiceert Adaptive Pathways
We would like to inform you of the publication of the Adaptive Pathways workshop report. The European Medicines Agency (EMA) held this workshop in collaboration with the European Commission to gather the views and proposals from stakeholders on the adaptive pathways approach, in light of the practical experience gained during the pilot project EMA ran between March 2014 and August 2016, and to plan the next steps in the exploration of this concept. You can access the report, as well as the presentations and videos from the workshop, via the following link: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/events/2016/09/event_detail_001324.jsp&mid=WC0b01ac058004d5c3
The adaptive pathways concept is an approach to medicines approval that aims to improve patients’ access to medicines in cases of high unmet medical need. To achieve this goal, several approaches are envisaged: identifying small populations with severe disease where a medicine’s benefit-risk balance could be favourable; making more use of real world data where appropriate to support clinical trial data; and involving health technology assessment (HTA) bodies early in development to increase the chance that medicines will be recommended for payment and ultimately covered by national healthcare systems.
You can also access more general information on the adaptive pathways concept via the following: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000601.jsp&mid=WC0b01ac05807d58ce
We would be grateful if you could disseminate this email to anyone else who might be interested.
Stakeholders and Communication Division
European Medicines Agency
30 Churchill Place
London, E14 5EU