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- Clinical Standards Draft Guidance on Data Standardization Planning (CBER/CDER/CDRH)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
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