Effective January 1, 2008, all electronic submissions submitted to FDA in the United States must be in eCTD format. This deadline is forcing organizations within the pharmaceutical industry to evaluate the transition from submitting paper documents to submitting electronic documents to global regulatory agencies.
The transition from paper documents to electronic documents encompasses many areas within an organization and integrates technology with regulatory requirements for submission and regulatory document preparation. This presentation highlights the things sponsors, CROs, testing facilities, and medical writers need to know about the impact of the eCTD on the industry and on their businesses.
The "Why" and "How" of eCTD Conversions was presented by Gina Ross, Director, Managing Consultant Regulatory Publishing Services, with Beckloff Associates a Cardinal Health Company and aired on 2008-01-31. For more details or to download this conference, please visit our site at www.fxconferences.com
