This course will provide techniques for uncovering potential drug safety signals, as well as expert instruction on the role of data mining in signal detection.

WHAT YOU WILL LEARN
• Why signal detection is needed
• Regulatory requirements
• Approaches to signal detection
• Good pharmacovigilance practices
• Data mining fundamentals
• How to use the Bayesian Confidence Propagation Neural Network (BCPNN)
• Review formulae for determining Proportional Reporting Ratio (PRR) and Multi-Item Gamma Poisson Shrinker (MGPS)



Learning Objectives:
At the conclusion of this course, participants should be able to:
• Explain the basic concepts and principles of signal detection
• Outline how to apply these techniques within their company
• Employ data mining techniques to analyze large volumes of adverse event report data

Target Audience:
Professionals who work in:
• Clinical Safety and Pharmacovigilance
• Pharmacoepidemiology
• Regulatory affairs

Event Code:
10417