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This module is part of the DIA Drug Safety eLearning Program. The Postmarketing Safety Management module provides a framework and details around drug safety monitoring requirements for drugs after they are approved for marketing. This module provides information about spontaneous reporting, aggregate reporting, risk assessment, benefit-risk management, risk management plans, and risk evaluation and mitigation strategies (REMS).

Featured topics

  • Spontaneous Case Reporting
  • Aggregate Reporting
  • Benefit-Risk Assessment
  • Risk Management Plans
  • Risk Evaluation and Mitigation Strategies (REMS)
  • Postmarketing Case Studies

Who should attend?

Professionals working in the area of:

  • Drug safety & pharmacovigilance
  • Clinical research and development
  • Marketing approval
  • Postmarketing activities
  • Regulatory affairs
  • Medical affairs
  • Quality assurance/compliance
  • Anyone who would like to enhance their knowledge and understanding of drug safety

Learning objectives

Upon completion of this course, participants should be able to:

  • Define spontaneous reporting and describe the spontaneous reporting system
  • Describe requirements for aggregate reporting of spontaneous reports
  • Describe the presentation of risks required in US labeling
  • Describe the efforts that have been made internationally to standardize benefit-risk assessment in the postmarketing phase
  • Describe risk management plan requirements in the EU
  • Describe risk evaluation and mitigation strategies (REMS) that are required in the US during postmarketing

This module takes an average of 3 hours to complete.

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