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#25: Signal Detection: Identifying and Managing Safety Signals

Tutorial name:
#25: Signal Detection: Identifying and Managing Safety Signals

Day & Time:
June 14, 8:30AM - 12:00PM

Room Number:

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Signal detection is an essential element of the overall risk management process. This intermediate to advanced tutorial 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 tutorial also provides participants with the context to evaluate new research in the field.

Learning Objective(s):
At the conclusion of this tutorial, 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.

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