22 June 2012

CTD and eCTD: dossier preparation and submission - Basic seminar

The topics

    CTD and eCTD document structure in detail
    Special features of Module 1
    Module 2-5: Data quality, efficacy and safety
    From CTD to eCTD NeeS over - the most important stages
    eCTD: Submission and challenges in creating practical


This course provides students with comprehensive knowledge base for the preparation and submission of registration dossiers. The first day focuses on the essential data. You will learn how data must be processed and where they are integrated into the CTD dossier.

The second day focuses on the dossier submission and provides a route of about Nees CTD to eCTD. You will receive information on structures, procedures and time frames and find out when a document "eCTD-ready". A Workshop on eCTD creation with lots of tips and tricks for practical implementation completes the program.

Contact person

Elsa Eckert
Conference Manager Pharmaceuticals

+49 6221 500-650

To find more information and Registration please use the below mentioned weblink


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