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.
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.
