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 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.
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.
This document is an official release note from the Maintenance and Support Services Organization (MSSO) detailing the changes and updates introduced in MedDRA (Medical Dictionary for Regulatory Activities) Version 28.1, released in September 2025. MedDRA is a standardized medical terminology used for regulatory communication and data analysis in the healthcare industry.
In the complex, globalized world of pharmaceuticals, clear communication is a matter of patient safety. MedDRA (the Medical Dictionary for Regulatory Activities) is the critical, standardized terminology that ensures a "heart attack" in a report from Japan is understood identically by a regulator in Europe. This article explores how this universal language powers...
These are the official bodies in each country where you can report suspected side effects of medicines, vaccines, and quality issues.
Advancing Medication Safety Through Knowledge and Vigilance
