Overview

This module provides a practical framework for monitoring and managing drug safety after approval. It covers key processes, including spontaneous and aggregate reporting, risk assessment, benefit-risk management, risk management plans, and Risk Evaluation and Mitigation Strategies (REMS). A case study with exercises gives learners a real-world context for applying these concepts.

The module takes an average of 3.5 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).

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
- Post-Marketing Safety Management Examples

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
- 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

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Post-Marketing Safety Management

Overview

Featured topics

Who should attend?

Learning objectives

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