Post-Marketing Safety Management

The Post-Marketing Drug Safety 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). 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 will be presented.

The module takes an average of 4.5 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).

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

-Previous Participant

• 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
• Post-marketing real-world case studies

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

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