This document is an official guideline from the EMA, finalized in October 2015. Its primary purpose is to provide standardized, clear instructions for all stakeholders in the European Union (EU) on how to handle medication errors within the pharmacovigilance (drug safety monitoring) system. The goal is to improve public health by ensuring consistent...
This WHO document is a practical guide and handbook specifically focused on the pharmacovigilance of medicines used to treat tuberculosis (TB).
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.
Advancing Medication Safety Through Knowledge and Vigilance
