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.
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.
