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.
This audio conference covers:
- Requirements and concepts of the eCTD
- How to evaluate and modify existing document preparation processes and procedures
- How to communicate with upper management to implement organizational change from paper to eCTD
- How to interface with vendors to receive electronically-compliant deliverables
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
- Regulatory Submissions
- Medical and Scientific Writers
- Document Management
- Document Publishers
- Quality Reviewers
- IT Personnel
*Please note: Each registration covers one line connected to the audio conference. Attendees dialing from separate locations are required to have separate registrations.