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.

This audio conference covers:

• The concept of the Common Technical Document (CTD)
• The concept of the electronic Common Technical Document (eCTD)
• The process for submitting regulatory applications in eCTD format
• How to decide if the eCTD is right for your company
• Implementing in-house solutions vs. outsourcing eCTD preparation

About the speaker:

Gina A. Ross has been involved in the pharmaceutical industry for over nine years, and for most of that time has managed the document preparation department for Beckloff Associates, Inc. (BAI), a pharmaceutical research and scientific consulting firm. She was instrumental in implementing the Common Technical Document (CTD) format in her own organization. Beginning in August 2000, she began researching how to implement electronic document management and electronic submission capabilities within BAI.

In 2002, she identified an electronic document management system and actively participated in the validation and implementation. BAI submitted its first electronic submission in December 2004. Since that time, Gina has overseen the submission of multiple electronic submissions, including original submissions, amendments, annual reports, and supplements, and the implementation and validation of eCTD software. Recently, she has managed the submission of several original eCTDs to the Office of Generic Drugs (OGD) and to various divisions within FDA. She has also given numerous presentations on CTD and eCTD implementation.

Who should attend?

• Regulatory Affairs
• Medical and Scientific Writers
• Document Management
• Document Publishers
• Quality Reviewers
• IT Personnel
• Regulatory Submissions

This audio conference is rated General Interest.