• Create an efficient, compliant, multidisciplinary process for signal detection and management
• Integrate data mining within an overall system of product safety risk management
• Read and interpret outputs from automated data mining analyses
• Prioritize and evaluate signals from all sources (including data mining)
• Understand how regulatory authorities use data mining to monitor product safety
  

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

• Clinical safety and pharmacovigilance
• Pharmacoepidemiology
• Regulatory affairs
• Benefit-risk management
• Information technology supporting pharmacovigilance activities
• Project management

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

• Lead the implementation of an integrated signal detection and management project
• Identify strengths and limitations of specific data sources and methods for signal detection and evaluation
• Interpret outputs from automated quantitative signal detection methods (data mining results) 
• Discuss setting up triage and prioritization procedures for safety signals
• Apply structured medical assessment to safety signal evaluation
• Design governance processes for signal escalation, decision-making, action and communication
• Integrate safety signal management into overall risk management
• Anticipate regulatory responses to data mining results