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

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TitleEuropean Medicines Agency stakeholder interaction on the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH)
Date03/12/2018 - 03/12/2018
LocationEuropean Medicines Agency, London, UK
SummaryThis 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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Live broadcast

  • 3 December 2018
    09:00 - 17:00 UK time

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Registration

  • Registration open until 31/10/2018
  • Places limited

Video recording

A video recording will be made available after the event.

Contact point:

Monica Simeoni: monica.simeoni@ema.europa.eu
Joachim Musaus: joachim.musaus@ema.europa.eu