Table of Contents
Evaluation Processes and Methods
Value of Risk Management Program (RMP) Evaluation
Pretesting RMP Tools Allows:
Approaches To Evaluation
Approaches To Evaluation
Evaluation Methods
Outcome Measures for Tools, Objectives, or Goals
Limitations of Current Evaluation Methods
Limitations of Current Evaluation Methods
PPT Slide
Elements of a Risk Management Program Submission
Overview
Background Section
Background Section
Goals, Objectives, and Level Section
Goals, Objectives, and Level Section (cont.)
Goals, Objectives, and Level Section (cont.)
Tools Section
Tools Section (cont.)
Tools Section (cont.)
Evaluation Plan Section
Evaluation Plan Section (cont.)
Reports to FDA
PPT Slide
Afternoon: Invited Commentary
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Home Page: http://www.fda.gov/cder/meeting/riskManagement.htm
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