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

Venue: Hotel Taj Banjara

Location: Hyderabad, ??, India

Event Date/Time: Jan 21, 2011 End Date/Time: Jan 22, 2011
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Description

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, thistraining course addresses Quality by Design aspects and issues.

Event Code: 11661

Venue

Wellington Business Park
Hyderabad
??
India
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