U.S. Food and Drug Administration • Center for Drug Evaluation and Research
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Electronic ICSRs The US Pilot
Electronic ICSRs US Pilot
Electronic ICSRs US Pilot: CDER AERS Pilot
ELECTRONIC ICSR US Pilot CDER: Pilot Status
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
ELECTRONIC ICSR US Pilot CDER: Accomplishments
ELECTRONIC ICSR US Pilot CDER: Accomplishments (cont’d)
ELECTRONIC ICSR US Pilot CDER: Next Steps
ELECTRONIC ICSR US Pilot CDER: Pilot Registration
ELECTRONIC ICSR US Pilot CDER: Additional Information
ELECTRONIC ICSR US Pilot CDER: Additional Information(cont’d)
Electronic ICSRs US Pilot: FDA’s ESTRI Gateway Overview (Electronic Standards for the Transmission of Regulatory Information)
Discussion Topics
Why A Gateway ?
What Does the Gateway Do ?
More Key Functions
PPT Slide
What Are the Gateway Components ?
Conceptual Overview
What’s In the TPIP ?
Required Message Structure
What Have We Learned From the Pilot ?
EDI Header & Trailer (ISO 9735)
Where Can We Go From Here ?
Need More Gateway Information ?
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