Post-Marketing Safety Management eLearning Module

Course Badges

Post-marketing Safety Management

Keyword(s) Drug safety, Pharmacovigilance, Good pharmacovigilance practices, Spontaneous reports, Aggregate reporting, Benefit-risk Assessment, Risk Minimization Plans, Risk Evaluation and Mitigation Strategies (REMS)

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 also be presented.

Credit Information ACPE = 4.5
IACET = .5

Tag(s) eLearning, Safety & Pharmacovigilance, Clinical Research, Regulatory Affairs, Medical Writing, Marketing & Sales

Description

Part of the DIA Drug Safety eLearning Program

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 real-world case studies

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

This module takes an average of 4.5 hours to complete.