The 7th Annual Electronic Submissions Conference ECTD: The Adventure Continues

Venue: Westin San Diego

Location: San Diego, California, United States

Event Date/Time: Nov 05, 2008 End Date/Time: Nov 07, 2008
Report as Spam

Description

The eCTD is rapidly moving towards the preferred, and in some cases mandated, electronic submission format world-wide. As of January 1st of this year, FDA mandated the eCTD format for all electronically submitted new applications and supplements. Beginning on July 1st, eCTD is the preferred electronic format for submitting dossiers in the European Centralized Procedure and many of the European National Competent Authorities are well ahead of the targeted 2009 date for accepting eCTDs.

This conference will focus on the practical experience gained, lessons learned, and the resulting best practices as the industry moves to a fully electronic submission paradigm. Topics will be presented that facilitate a better understanding of the eCTD submission development process, eCTD submission standards, and their impact to business processes. Regulatory Authority representatives will also present the latest guidance and discuss the future direction of the eCTD… the adventure continues.

This program has been developed by the DIA the Document and Records Management, eClinical, Electronic Regulatory submissions, Medical Writing, and Regulatory Affairs Special Interest Area communities.

Venue

400 West Broadway
San Diego
California
United States
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