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

Date(s) And Time(s):
Mar 24 2010 8:00AM - Mar 25 2010 5:00PM

Location:
Taj Banjara
Road No. 1
Banjara Hills
Hyderabad 500034
Andhra Pradesh
India

Contact: http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?pr...

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

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

Overview:

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.