This document is a training presentation from the Uppsala Monitoring Centre (UMC) about VigiFlow, which is an internet-based system for managing Individual Case Safety Reports (ICSRs). The primary focus is on how a country can implement a decentralised structure within VigiFlow to distribute pharmacovigilance (PV) activities beyond the national PV centre.
Staying updated with clinical guidelines is crucial, but translating them into daily practice can be a challenge. The 2022 American Association for the Study of Liver Diseases (AASLD) practice guidance on Drug-Induced Liver Injury (DILI) is a landmark document. To make it instantly actionable, we've distilled its core principles into a clear, concise...
The economic value of Pharmacovigilance (PV) is profound and multifaceted, extending far beyond a simple regulatory cost. A robust PV system is not an expense but a critical strategic investment that protects and generates significant financial value for pharmaceutical companies, healthcare systems, and society as a whole.
Pharmacovigilance (PV) for herbal medicines is a critical and complex field, often referred to as Phytovigilance. The core principle is the same as for conventional pharmaceuticals: to ensure the safety of patients by detecting, assessing, understanding, and preventing adverse effects. However, the practice of PV for herbal medicines presents unique and significant challenges.
Here is a detailed guideline for Cosmetovigilance, structured similarly to a pharmacovigilance guideline, but based on the core principles of EU Cosmetics Regulation (EC) No 1223/2009.
The "5 Rights of Medication Administration" are a fundamental framework in patient safety designed to prevent medication errors at the point of care. They serve as a critical final check for healthcare professionals, especially nurses, before a medication is given to a patient.
This guideline provides international standards and definitions for managing and reporting safety information for medicines after they have been approved and are on the market (the "post-approval" or "post-marketing" phase). Its goal is to ensure that safety data is collected, evaluated, and reported consistently and with high quality across different regions.
Advancing Medication Safety Through Knowledge and Vigilance
