Safety Operations
Explore all topics, guides, and frameworks related to Safety Operations.
Articles in this section
7- Medical Literature Monitoring in Pharmacovigilance Explains how literature monitoring supports ICSR collection and safety surveillance, what EMA's central MLM service does, which responsibilities remain with marketing-authorisation holders, and how literature evidence should flow into case management and signal evaluation. Read Article →
- EudraVigilance Registration and Access Management EudraVigilance access is built around registered organisations, individual EMA accounts and role-based approvals. This article explains the current EMA Account Management and Organisation Management Service workflow, the roles of the QPPV or responsible person, trusted deputies, EVDAS and level 2B access, transmission modes, training and lifecycle controls. Read Article →
- EudraVigilance Metrics and KPIs for QPPVs EudraVigilance KPIs should reveal whether regulated safety processes are effective, not merely count workload. This article explains the legal and GVP basis for performance monitoring, distinguishes mandatory reporting timelines from organisation-defined KPI thresholds, and provides a risk-based dashboard model for QPPV oversight. Read Article →
- EudraVigilance Reporting: A Practical Guide to ICSR Submission EudraVigilance reporting is an end-to-end regulated process from receipt of safety information to accepted E2B(R3) submission and subsequent follow-up. This article explains current EU post-authorisation ICSR reporting rules, reporting pathways, acknowledgement handling, data quality, corrections, compliance monitoring and QPPV governance. Read Article →
- EudraVigilance Inspection Findings and Failure Modes EudraVigilance inspection readiness depends on effective pharmacovigilance processes rather than a separate set of EV-only controls. This article uses published EMA inspection information to distinguish documented finding areas from illustrative failure modes and explains how inspectors can trace ICSR reporting, acknowledgements, data quality, signal management, access, vendors, deviations and QPPV oversight. Read Article →
- XEVMPD Guide for Pharmacovigilance Professionals Understanding XEVMPD, medicinal product data management, regulatory requirements, inspection readiness and QPPV oversight responsibilities. Read Article →
- What is EudraVigilance? A comprehensive introduction to EudraVigilance, electronic safety reporting, EVWEB, E2B(R3), case downloads and the role of EudraVigilance within the European pharmacovigilance system. Read Article →