概要

Signal detection is an essential element of the overall risk management process. This short course provides a concise review of current methods of drug safety signal detection for marketed products and the role of signal detection within the larger signal and risk management process. Emphasis is on practical pragmatic approaches. Outputs from quantitative signal detection will be the basis for a hands-on exercise and discussion. The short course also provides participants with the context to evaluate new research in the field.

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参加対象

This short course is designed for members of clinical safety and pharmacovigilance organizations who oversee, manage, or perform signal detection activities. This course will also benefit participants who make risk management decisions based on signal detection results.

学習目的

At the conclusion of this course, participants should be able to:

Identify strengths and limitations of methods for signal detection
Interpret outputs from automated quantitative signal detection methods (data mining results)
Discuss how to integrate signal detection methods into the larger signal and risk management process
Describe emerging methods for signal detection

#23: Signal Detection: Identifying and Managing Safety Signals

DIA 2017 is located at:

概要

参加対象

学習目的

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