Overview

Signal detection plays a critical role in monitoring the safety of medical products and continuously evaluating their benefit-risk profiles in real-world use. This module introduces the fundamentals of signal detection in pharmacovigilance, including key concepts, available safety databases, data mining and statistical methods, principles of pharmacoepidemiology, and the regulatory context for interpreting and acting on safety signals.

The module takes an average of 3.5 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).

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 safety databases and information contained in each database
- 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 Council for International Organizations of Medical Sciences (CIOMS) VIII principles for signal detection

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Basics of Signal Detection, Management, and Pharmacoepidemiology

Overview

Featured topics

Who should attend?

Learning objectives

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