DIA, Hyderabad, India
Mar 24 2010 - Mar 25 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. The course is for new developments, but is also very much attractive for Generics. In addition, this training course addresses Quality by Design aspects and issues.
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