EDM and ERS/eCTD Tutorial 1: eCSRs
Oct 15 2013 8:00AM - Oct 15 2013 11:30AM | Town and Country Resort and Convention Center
500 Hotel Circle North
San Diego, CA 92108
This tutorial will examine the myriad of issues around the authoring and publishing of clinical study reports and their related components for electronic submissions. This includes but is not limited to document granularity, hyperlinking and bookmarking, best practices for US and EU, as well as the relationship between tables, figures and listings and the data that is submitted to the FDA. A member of the eDATA team from the Center for Drug Evaluation and Research FDA will provide insight into how the data from study reports are utilized by the agency during the course of application assessments.
Who Should Attend
Regulatory Affairs/Operations, Medical Writers and Data/Project Managers who wish to gain a better understanding of the challenges of authoring and compiling clinical study reports and the supportive documentation and data that are used to evaluate them.
At the conclusion of this tutorial, participants should be able to:
- Recognize and utilize granular CSRs for submissions
- Determine best practices for publishing standards for clinical reports
- Incorporate the agency and reviewer’s needs into standards and processes for clinical submissions
Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.
Participants with Disabilities:
Reasonable accommodations will be made available to persons with disabilities who attend an educational activity. Contact the DIA office in writing at least 15 days prior to event to indicate your needs.