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

Date(s) And Time(s):
Apr 26 2010 8:00AM - Apr 28 2010 5:00PM

Location:
Hotel Austria Trend Savoyen
Rennweg 16
1030 Vienna
Austria

Overview:

High Quality of a registration dossier facilities the registration procedure - Essential 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.

Contact Information:
DIA Europe
4002 BASEL
SWITZERLAND
TEL.: +41 61 225 51 51
E-MAIL: DIAEUROPE@DIAEUROPE.ORG

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