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

Hotel Taj Banjara
Road No.: 1, Banjara Hills
Hyderabad - 500 034
Phone: +91-040-66663939

Event Code: 11661
JANUARY 21-22, 2011

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

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.