Anne Gervais
Anne Gervais PharmD, Global Regulatory Affairs, Specialty Care, Rare Diseases, Sanofi, Marcy l’Etoile, France
JournalThe regulatory valuation of patient experience data in rare diseases: A review of FDA and EMA labelling outcomes and methodological determinants
This article summarises a review carried out to evaluate patient experience data inclusion in regulatory assessements and labelling for rare diseases in the EU and the US