Safety and pharmacovigilance
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Pharmacovigilance identifies and assesses medicine risks and supports action to prevent or minimise harm throughout the product lifecycle. The parts divide by the work and documents involved: the discipline and its legal framework, case processing and signals, aggregate reports, risk management, safety studies, the system master file, and guidance for particular products and populations. Trial-site safety reporting, device safety documents, and pharmacovigilance specific to generics and biosimilars belong to neighbouring concerns.
- What pharmacovigilance covers and why it exists — objectives and history, the limits of pre-authorisation evidence, company systems, risk management and patient involvement
- The DSUR, the RMP and the PSUR across the lifecycle — how the three documents fit together, their inputs and workflow, post-marketing writing practices and continuing updates
- Case reports and signals — safety information sources and databases, processing individual cases, and managing signals through assessment, action and communication
- Periodic safety reports — formats and regional obligations, the development safety update report, Japan’s reports, production to deadline and authority assessment comments
- Risk management — the EU plan, safety concerns, risk minimisation, public disclosure, guidance changes and production, and the US risk evaluation and mitigation strategy
- Post-authorisation safety studies and their reports — study types, protocols, registration and results posting, the final report’s contents and regulatory submission
- The pharmacovigilance system master file — documenting the holder’s system, processes, responsibilities, metrics, annexes, logbook, deviations and audits
- Product- and population-specific pharmacovigilance guidance — additional considerations for biological medicines, children and vaccines
- What the 2012 European reform changed — legislation and practice modules, benefit–risk assessment, reporting and publication changes, product-data duties, implementation and measured impact