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Basic Safety Sciences: Pharmacoepidemiology, Clinical Pharmacology, Pharmacogenomics, and Toxicology Studies eLearning Module

Learn the principles of safety sciences including toxicology, clinical pharmacology, pharmacogenomics, and pharmacoepidemiology in order to analyze potential safety issues.

Overview

This eLearning course provides a comprehensive foundation in the core safety sciences, nonclinical toxicology, clinical pharmacology, pharmacogenomics, and pharmacoepidemiology, equipping you with the skills to evaluate safety risks and understand patient impact throughout drug development. Through integrated examples and applied learning activities, you will explore how each discipline informs the progression of a drug candidate from early discovery through first-in-human studies, highlighting the scientific rationale, decision points, and evidence required at each stage. The course also examines how safety and pharmacovigilance practices adapt to a continually evolving landscape shaped by new technologies, regulatory expectations, and advances in our understanding of human biology and patient diversity.

The module takes an average of 8.5 hours to complete.

This eLearning module can be purchased individually or as part of the Drug Safety eLearning Bundle (7 modules).

Featured topics

    • Toxicology
    • Clinical pharmacology
    • Pharmacogenomics
    • Pharmacoepidemiology

Who should attend?

  • This module is designed for professionals working in:

    • Drug safety and pharmacovigilance
    • Clinical research and development
    • Quality assurance and compliance
    • Regulatory affairs
    • Medical affairs
    • Medical writing

      Learning objectives

      • Upon completion of this course, learners should be able to:

        • Differentiate between the types of nonclinical toxicology studies and their role in determining a drug’s safety profile before beginning human clinical trials.
        • Identify platform-specific toxicology requirements for small molecules, biologics, cell and gene therapies, and vaccines.
        • Recognize the limitations of nonclinical toxicology data in concordance between animal models and human outcomes in drug development.
        • Outline the basic principles of clinical pharmacology.
        • Recognize the fundamentals of pharmacogenomics.
        • Utilize the principles of pharmacoepidemiology and other drug safety sciences to analyze potential safety issues.
        • Classify the patient population using the principles of pharmacoepidemiology and other drug safety sciences.

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