OHP-042 Impact of the Paediatric Regulation on the environment of paediatric medicines use: paediatric investigation versus off-label drug use

Abstract

BackgroundIn 2006, the European Parliament approved paediatric standards (Paediatric Regulation 1901/2006) in order to stimulate the development of paediatric clinical trials (PCT) reducing off-label drug use (ODU).PurposeTo evaluate the variation...