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