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

The Pride Hotel
93 Richmond Road
Bengaluru - 560 025

JANUARY 18-19, 2011, Bangalore, INDIA

http://www.diahome.org/DIAHome/Home.aspx

Techniques to Ensure High Quality Registration Dossiers Facilitate
the Registration Procedure for Generics.
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.
Register early

Contact Info:
Fahd Khan, Manager Marketing & Program Development, DIA (India) Private
Limited; Cell: +91-9223267327, Fax: +91-22-28594762, Email: fahd.Khan@diaindia.org