Basics of Signal Detection and Pharmacoepidemiology
Overview
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
Featured topics
- Safety signal basics
- Safety databases
- Data mining and the use of statistics in drug safety
- Principles of pharmacoepidemiology
- Signaling regulations and guidances
Who should attend?
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
Learning objectives
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