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Drug Safety eLearning Bundle

Explore the basics of drug safety and safety sciences in this seven module eLearning bundle.

Perspectiva general

The Drug Safety eLearning Bundle includes seven self-paced modules:

Learners have access to the eLearning modules 24 hours a day, 7 days a week for one full year, and are mobile compatible making it easy to learn on the go! Continuing education credits are offered for all modules.

The seven modules take an average of 31.25 hours to complete.

Temas destacados

  • Assessing cases
  • Reference safety information
  • Harmonization initiatives
  • Important US and EU regulations
  • Individual case and aggregate reporting
  • Benefit-risk assessment
  • Risk management plans and risk evaluation and mitigation strategies (REMS)
  • Safety signal basics and data mining
  • Types and scope of audits and inspections
  • Common inspection findings
  • Responding to an inspection
  • Corrective and preventative action plan
  • Toxicology
  • Clinical pharmacology
  • Pharmacogenomics
  • Pharmacoepidemiology

¿Quiénes deben asistir?

These modules are designed for professionals involved in:

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

Objetivos de aprendizaje

  • Module 1: Introduction to Drug Safety: 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
    • Determine the assessment of seriousness, expectedness, and causality of adverse events

    Module 2: Drug Safety Regulatory Requirements: Upon completion of this module, learners should be able to:

    • Identify key harmonization initiatives and important US and EU regulations
    • Recognize the roles that the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and Council for International Organizations of Medical Sciences (CIOMS) play in drug safety regulations
    • Define good clinical and pharmacovigilance practices and standard operating procedures (SOPs) that support drug safety

    Module 3: Pre-Marketing Clinical Trial Safety: Upon completion of this module, learners should be able to:

    • Identify the purpose and elements of informed consent in clinical trials
    • Determine the roles of institutional review boards, ethics committees, and data and safety monitoring boards in clinical trials
    • Recognize pre-marketing individual case reporting, aggregate reporting requirements, and review of safety data in marketing application
    • Define risk assessment in clinical trials

    Module 4: Post-Marketing Safety Management: Upon completion of this module, learners should be able to:

    • Define spontaneous reporting and describe the spontaneous reporting system
    • Identify the requirements for aggregate reporting of adverse events in marketed products
    • Recognize the presentation of risks required in US labeling and the efforts that have been made internationally to standardize benefit-risk assessment in the post-marketing phase
    • Compare risk management plan requirements in the EU with risk evaluation and mitigation strategies (REMS) that are required in the US during post-marketing

    Module 5: Basics of Signal Detection and Pharmacoepidemiology: Upon completion of this module, 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

    Module 6: Safety Audits and Inspections: Upon completion of this module, learners should be able to:

    • Identify FDA inspections, possible sanctions, and how a company should respond to an FDA inspection, including the Corrective and Prevention Action (or CAPA) Plan
    • Differentiate European Medicines Agency (EMA) and Medicines and Healthcare products Regulatory Agency (MHRA) inspections, the legal basis for European inspections, the new European guidelines on pharmacovigilance inspections, the MHRA’s risk-based approach, and possible sanctions
    • Recognize Health Canada safety inspections and after-inspection activities
    • List inspection findings common to both FDA and MHRA, and to each agency individually
    • Determine best practices for the company's management of audits and inspections

    Module 7: Basic Safety Sciences: Pharmacoepidemiology, Clinical Pharmacology, Pharmacogenomics, and Toxicology Studies: Upon completion of this module, learners should be able to:

    • Identify the basics of toxicology studies>/LI>
    • Recognize the limitations in predicting human toxicity
    • 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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