Risk management : a European regulatory perspective
Related Experiment Video
Updated: Aug 24, 2026

An R-Based Landscape Validation of a Competing Risk Model
Published on: September 16, 2022
1Pharmacoepidemiology Research Team, The Medicines and Healthcare products Regulatory Agency, London, United Kingdom.
Abstract:
Risk management for European regulators means the detection and assessment of risks, the development and selection of measures to reduce risk, and monitoring of the effectiveness of risk control; all aspects of pharmacovigilance intended to minimise risk to European Union citizens associated with use of medicinal substances. This incorporates earlier and better planning of pharmacovigilance through formal product risk-management plans, better use of information tools to protect public health and routine audit of effectiveness of regulatory action.
Related Concept Videos
Drug Control Governance: Regulatory Bodies and Their Impact
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast, controlled...
Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions
Drug Regulation
Pharmacovigilance
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
Hazard Rate