CTD Dossier Requirements:Focus on EU Module 1 and Quality Module 3
Venue: The Pride Hotel
|Event Date/Time: Jan 18, 2011||End Date/Time: Jan 19, 2011|
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.
Event Code: 11660
This course has limited capacity.