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


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.

Date(s) And Time(s):
Mar 21 2010 8:00AM - Mar 22 2010 5:00PM

Scitech Centre
Prabhat Road off S. V. Road
Jogeshwari West
Mumbia 400102

Interest Area(s):
Regulatory Affairs, Clinical Research, Public Policy/Law/Corp. Compliance, Research & Development, Project Management

Contact Information:

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