The evaluation of the safety profile of medicine approved through accelerated procedures using da...

Employer
Università degli Studi della Campania
Location
Italy
Posted
October 02 2017
Position Type
Full Time
Organization Type
Academia

The aim of the project is to evaluate the safety profile of medicine approved through accelerated procedures using spontaneous adverse drug reaction reported in Eudravigilance database. FDA established the accelerated approval pathways in 1992 (fast track process) for drugs indicated for serious diseases for which there is no proven effective therapy. This process, which is frequently applied to drugs for cancer diseases, allows to obtain an early marketing authorisation and consequently an early access for patients, even when clinical development is not completed or when the efficacy profile is evaluated on surrogate endpoints. In 2004, also the European Medicines Agency (EMA) introduced this kind of accelerated procedures, the “adaptive licensing”



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