CTD Dossier Requirements:Focus on EU Module 1 and Quality Module 3

Venue: The Pride Hotel

Location: Bangalore, India

Event Date/Time: Jan 18, 2011 End Date/Time: Jan 19, 2011
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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.
Event Code: 11660
This course has limited capacity.
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