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Electronic ICSRs The US Pilot
Electronic ICSRs US Pilot
Electronic ICSRs US Pilot: #11; CDER Pilot Perspective
PPT Slide
ELECTRONIC ICSR US Pilot CDER: Functions to Implement
ELECTRONIC ICSR US Pilot CDER: Processing AE data
ELECTRONIC ICSR US PILOT CDER: Storing Reports
ELECTRONIC ICSR US Pilot CDER: Agency Requirements
ELECTRONIC ICSR US Pilot CDER: Agency Requirements (cont’d)
ELECTRONIC ICSR US Pilot CDER: Project Status
E*Prompt Phases
ELECTRONIC ICSR US Pilot CDER: Development/Test Phase
ELECTRONIC ICSR US Pilot CDER: Pilot Production Phase
ELECTRONIC ICSR US Pilot CDER: Production Phase
ELECTRONIC ICSR US Pilot CDER: Next Steps
ELECTRONIC ICSR US Pilot CDER: Additional Information
ELECTRONIC ICSR US Pilot CDER: Additional Information(cont’d)
Electronic ICSRs US Pilot: FDA Gateway Perspective
Presentation Outline
FDA ESTRI Gateway Capability
FDA ESTRI Gateway Gateway Components Conceptual Overview
FDA ESTRI Gateway Trading Partner Information Package
FDA ESTRI Gateway Trading Partner Information #11; Package
FDA ESTRI Gateway #11; How to get started
FDA ESTRI Gateway Industry Partners
FDA ESTRI Gateway #11; Lessons Learned
For More Information on the FDA ESTRI Gateway contact:
Download presentation source
Last update: July 11, 2005
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