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.
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.
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