This module is part of the DIA Drug Safety eLearning Program. The Basics of Signal Detection and Pharmacoepidemiology module provides an introduction to signal detection in pharmacovigilance. The module provides information about safety signal basics, safety databases, data mining and the mathematics of drug safety, principles of pharmacoepidemiology, and signaling regulations.
- Safety Signal Basics
- Safety Databases
- Data Mining and the Mathematics of Drug Safety
- Principles of Pharmacoepidemiology
- Signaling Regulations
Who should attend?
Professionals working in the area of:
- Drug safety & pharmacovigilance
- Clinical research and development
- Marketing approval
- Postmarketing activities
- Regulatory affairs
- Medical affairs
- Quality assurance/compliance
- Anyone who would like to enhance their knowledge and understanding of drug safety
Upon completion of this course, participants should be able to:
- Define a safety signal and list the activities in signal management
- List different safety databases and the information each contains
- Explain the mathematics of drug safety, data mining, and its role in signal detection
- Define pharmacoepidemiology and explain its role in drug safety management
- Explain signaling regulations in the US and EU, and CIOMS VIII principles for signal detection
This module takes an average of 3.5 hours to complete.