The Westin San Diego Hotel , San Diego, CA
Oct 28 2010 8:00AM - Oct 29 2010 5:00PM
Call for Abstracts
Abstract Submission Guidelines
Please submit all presentation abstracts using the online form at:
All abstracts must be received by June 25, 2010.
Authors of selected abstracts will be notified by September 13, 2010.
SUGGESTED ABSTRACT TOPICS
• Global Submission Strategies
Other Regional Electronic Submission Formats, including NeeS (Non-eCTD
Other Countries/Considerations (eg, ASEAN)
• Regulated Product Submission
• eCTD Issues and Lessons Learned
Life Cycle Management
• Other Electronic Submission Topics Associated with the Management of
Tutorials: October 27
Conference: October 28-29, 2010
Please monitor the DIA website for tutorials information and registration
The focus of this year’s meeting will be on developing and implementing an electronic submission strategy that will accommodate submission to one or many countries, including discussion of true simultaneous submission to regions. The use of the eCTD and its components is a key element to this approach. As eCTD matures and evolves into its next version it is crucial to know where in the world it is being used and is not only the recommended but required format. Also of note will be what issues have emerged pertinent to these uses. Since eCTD is not yet a global standard and many countries continue to use other regional electronic submission formats and paper, this conference will also focus on addressing the challenges associated with those formats. Also, key to this year’s conference will be collaborative working sessions on specific topics and ICH modules that will give participants the opportunities to interact and share the challenges they have faced and how they overcame them. These sessions will be facilitated by members of the program committee, each of whom has extensive expertise on these topics.