CTD Dossier Requirements Focus on EU Module 1 and Quality Module 4

Venue: Taj Banjara

Location: Hyderabad, India

Event Date/Time: Mar 24, 2010 End Date/Time: Mar 25, 2010
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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