Basics of Signal Detection and Pharmacoepidemiology

Signal detection has become an important tool for monitoring the safety of medical products and for continuously updating our understanding of the benefit-risk profiles of medical products in use by the general population. The ability to detect potential safety issues through signal detection has evolved rapidly in recent years with advances in technology, data sources, and methodologies. The Basics of Signal Detection and Pharmacoepidemiology module provides an introduction to signal detection in pharmacovigilance.

This module provides information about basic concepts of safety signal detection, currently available safety databases and their characteristics, data mining and the use of statistics in drug safety, principles of pharmacoepidemiology and the context for interpreting signaling results, and signaling regulations and guidance.

The module takes an average of 4 hours to complete.

This eLearning module can be purchased individually or as part of the Drug Safety eLearning Program (6 modules) or Drug Safety eLearning Bundle (7 modules).

“Excellent information and well-organized. The course lays out signal detection information in an easy to follow format with clear writing that is nice for the novice Pharmacovigilance user, while still providing good information for a seasoned professional like myself.”

- Previous Participant

• Safety signal basics
• Safety databases
• Data mining and the use of statistics in drug safety
• Principles of pharmacoepidemiology
• Signaling regulations and guidances

Professionals working in the area of:

• Clinical safety and pharmacovigilance
• Clinical research
• Biostatistics
• Bioinformatics
• Regulatory affairs
• Quality assurance
• Compliance
• Medical affairs
• Marketing
• Health and economic outcomes research

Upon completion of this course, learners should be able to:

• Define a safety signal and list the activities in signal management
• List different safety databases and the information each contains
• Recognize the use of statistics in drug safety, data mining, and their role in signal detection
• Define pharmacoepidemiology and explain its role in drug safety management
• Identify signaling regulations and guidances in the US and EU, and CIOMS VIII principles for signal detection