AERS

Table of Contents

Electronic Submissions:FDA’s Perspective

Topics for Today

AERS

Adverse Event Reporting System (AERS)

AERS Functionality

AERS: Users

Adverse Events Reports to FDA 1989 to 2001

AERS

Electronic Submissions - Developments

E-Sub Production

E-Submission vs Paper

Progress!

Impact of E-submissions

AERS

Administrative Information Elements

Data Element: Reporter

Data Element: Patient

Data Element: Adverse Event

Data Element: Product

AERS

FAQs

FAQs (continued)

Internet Sites:Electronic Submissions

Home Page: http://www.fda.gov/cder/present/index.htm