Meeting Program

This conference features three tracks with group sessions as well as interactive working sessions, which will give attendees the opportunity to interact with speakers, agency personnel and other participants in a dynamic and informative environment.

Session topics include:

  • FDA Update/eCTD Progress Report
  • PDUFA V eData Standards and eSubmissions
  • TMF Model and Implications
  • Clinical Standards Draft Guidance on Data Standardization Planning (CBER/CDER/CDRH)
  • The “Cloud” for the benefit of the  Content Continuum from Document Authoring through Submission Delivery. How is that done anyhow?
  • Moving to Content Management & Authoring: Steps for Change
  • CDISC SEND: Implementing Standardized Non-clinical Data in Submissions
  • "What the Future Holds" Implementing Process & Technology to be ready to Electronically Submit Advertising & Promotional Material
  • Successful Practices for Sponsor Collaborations

EDM and ERS/eCTD 2012

Conference Program - Now Available

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