12th Workshop, Barcelona: “Retooling the EU Orphan Drug Regulation and US Orphan Drug Act for Better and Faster Development of Rare Disease Therapies”
October 2023June 18th, 2010
Barcelona, Spain
A consensus was reached about using all the available tools offered by the current EU and US regulations, rather than starting a revision process for which the outcome would be rather uncertain. Several ways of improving the orphan drug regulations were evoked and solutions proposed to accelerate the development of orphan drugs on both sides of the Atlantic.
Participants: 61
Key feature: First time that a discussion bringing together all the stakeholders was taking place to reflect on the existing Orphan Drugs legislations both in the EU and US.
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Proceedings
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