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CTD Dossier Requirements Focus on EU Module 1 and Quality Module 4

  February 03, 2010  
DIA, Hyderabad, India
Mar 24 2010 - Mar 25 2010

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.

Organized by: Fahd Khan
Invited Speakers:

Call contact

Deadline for Abstracts: call contact

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

E-mail: Kanchan.patel@diaindia.org
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