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Introduction to Drug Safety

Develop the foundational knowledge required to work day-to-day in clinical safety and pharmacovigilance.

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概要

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).

特集トピック

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

参加対象

  • 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

      学習目的

      • 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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