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Session Chair(s)
Ron Fitzmartin, PHD, MBA
Principal Consultant
Decision Analytics, United States
Learning Objective : Discuss the clinical data life cycle; Assess how mapping after data capture can compromise traceability and regulatory review quality/efficiency; Illustrate how to design data capture systems based on protocol templates and CDISC/CDASH standards.
Speaker(s)
FDA Perspective
Benjamin Peter Behrang Vali, MS
FDA, United States
Regulatory Affairs Officer and Project Manager, DGIEP, OND, CDER
Protocol Standardization, Common Protocol Templates, and Data Standards: Streamlining Clinical Development
Robert DiCicco, PHARMD
TransCelerate Biopharma Inc., United States
Vice President, Portfolio Management
Realizing the Promise of End-to-End Standards through CFAST and CDISC SHARE
Wayne R. Kubick, MBA
HL7 International, United States
Chief Technology Officer
Panelist
Paula Brown Stafford, MPH
Health Decisions, Inc., United States
Board of Directors; Biopharmaceutical Services Executive
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