The electronic common technical document (eCTD) presents many challenges to a Sponsor organization, but may also yield significant benefits through increased efficiencies and improved reviews by regulatory agencies. Sponsor organizations that have decided to adopt the eCTD now have the challenging task of managing and implementing the paradigm shift from paper to electronic regulatory submissions.
The first of many challenges is to evaluate and modify existing document preparation processes to accommodate differences between paper and eCTD. Once these changes have been identified, the next step is to convince upper management the changes are necessary to move the organization forward to preparing electronic submissions. Another challenge is working with vendors to receive electronically-compliant documents. The eCTD requires sponsor organizations to rethink their business and those with whom they do business.
Managing the Shift to Electronic Submissions was presented by Gina Ross, Director, Managing Consultant, Regulatory Publishing Services, with Beckloff Associates a Cardinal Health and aired on 2008-04-17. For more information, or to download this audio conference please visit our site at www.fxconferences.com
