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Postmarketing Safety Management


Overview

This module provides a framework and details around safety monitoring requirements for drugs after they are approved for marketing. It provides information about spontaneous reporting, aggregate reporting, risk assessment, benefit-risk management, risk management plans in the EU, and risk evaluation and mitigation strategies (REMS) in the US. The module will present a case study with exercise questions, to provide real-world context and enable the learner to see how the concepts presented in the module apply in real life.


“This module was extremely helpful in providing knowledge about crucial information around key pharmacovigilance processes.”

-Previous Participant

Featured topics

  • Spontaneous Reporting
  • Spontaneous Reporting Case Study Activity
  • Aggregate Reporting
  • Benefit-Risk Assessment
  • Risk Management Plans in the EU
  • Risk Evaluation and Mitigation Strategies (REMS) in the US
  • Postmarketing Real-World Case Studies

Who should attend?

This module is designed for professionals involved in:

  • Clinical safety and pharmacovigilance
  • Clinical research 
  • Regulatory affairs
  • Quality assurance
  • Compliance
  • Medical affairs
  • Epidemiology
  • Outcomes research
  • Marketing

Learning objectives

Upon completion of this module, learners should be able to:

  • Define spontaneous reporting and describe the spontaneous reporting system
  • Discuss the requirements for aggregate reporting of adverse events in marketed products
  • Explain 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
  • Compare risk management plan requirements in the EU with risk evaluation and mitigation strategies (REMS) that are required in the US during postmarketing

This module takes an average of 4.5 hours to complete.

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