Mar 21 2010 - Mar 22 2010
Techniques to Ensure High Quality Registration Dossiers Facilitate the Registration Procedure for Generics.
This Module provides a comprehensive description on the Common Technical Dossier structure —
completely updated to reflect the latest changes in pharmaceutical regulatory affairs. The course is
focusing on the specific regional EU requirements for Module 1 including discussion of the relevant
legislation. The requirements for the Quality documentation (Module 2.3 & 3) will be presented in detail,
taking into account the recent ICH-Q guidelines.