European Medicines Agency stakeholder interaction on the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH)

Date: 03/12/2018
Location: European Medicines Agency, London, UK

This workshop on the development of medicines for chronic non-infectious liver diseases, including primary biliary cholangitis, primary sclerosing cholangitis and nonalcoholic steatohepatitis, provides a platform for discussion on appropriate endpoints including validation of surrogate endpoints/biomarkers, suitable study populations, potentially adequate trial designs and the specific challenges with paediatric medicine development. The workshop will support the drafting of a reflection paper on regulatory requirements for the development of medicines for the treatment of these diseases.



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