UNIT 2: Scope, Stakeholders, and Types of Pharmacovigilance
This unit explains how Pharmacovigilance operates across the medicinal product lifecycle and identifies the key stakeholders responsible for ensuring drug safety. It also details the different types and methods of pharmacovigilance used to detect, monitor, and evaluate safety issues in real-world settings.
Definition
PV starts from the day when the IND officially begins testing in humans during clinical trials and continues post-marketing until the drug remains in the market.
| Lifecycle Phase | Role of Pharmacovigilance |
|---|---|
| Clinical development | Identification of adverse events and safety trends in trials |
| Early post-marketing | Detection of rare and unexpected adverse reactions |
| Mature products | Continuous monitoring of benefit–risk balance |
| Post-authorization changes | Evaluation of new risks and effectiveness of risk minimization |
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