Overview

This module provides foundational knowledge essential for daily work in clinical safety and pharmacovigilance. It covers the evolution of pharmacovigilance, key definitions and tools, the regulatory framework for safety reporting, and core operational processes. Learners will also explore reference safety information from the Investigator’s Brochure and post-marketing labeling, along with the assessment of adverse events for seriousness, expectedness, and causality.

The module takes an average of 4.25 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

- Drug Safety Basics
- Terminology
- A Company Safety Unit
- Tracking a Case from Start to Finish
- Reference Safety Information
- Assessing Cases

Who should attend?

This module is designed for professionals involved in:
- Clinical safety and pharmacovigilance
- Clinical research
- Regulatory affairs
- Medical writing and marketing with a focused interest in pharmacovigilance

Learning objectives

Upon completion of this module, learners should be able to:
- Recognize the history, principles, and regulatory framework for clinical drug safety
- Define terms used in day- to-day pharmacovigilance work
- Identify a typical company drug safety unit and the path of a case from start to finish
- List Reference Safety Information provided by the Investigator's Brochure and post-marketing labeling
- Evaluate the seriousness, expectedness, and causality of adverse events

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Introduction to Drug Safety

Overview

Featured topics

Who should attend?

Learning objectives

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