This meeting is meant to be a follow up to the quality assessors meetings held in The Hague in 2010 and in Vienna in 2011. The aim of Prague training remains the same with focus on risk based approach towards assessment, minimization of duplication of work within Europe and also alignment of requirements around Europe. Since the biggest part of assessor´s work is assessment of generic medicines this year training will be focused also on issues related to assessment of generics and in vivo- in vitro correlation, and properties of drug substance that can influence this correlation.
Information on registration for the training as well as on hotel reservation and other practical information can be found in the document “Practical Information” attached hereinunder.
