The Pride Hotel
93 Richmond Road
Bengaluru - 560 025
JANUARY 18-19, 2011, Bangalore, INDIA
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.
This course has limited capacity.
Fahd Khan, Manager Marketing & Program Development, DIA (India) Private
Limited; Cell: +91-9223267327, Fax: +91-22-28594762, Email: fahd.Khan@diaindia.org