Reporting Side Effects

This is a fundamental concept in pharmacovigilance (drug safety monitoring). Let's break down the Important Medical Event (IME) List from MedDRA with a clear illustration.

This document is an official guidance from the U.S. Food and Drug Administration (FDA) issued in December 2025. It provides the agency's current recommendations and interpretations on how clinical investigators (the doctors/researchers running clinical trials) should handle safety reporting for drugs and medical devices that are still under investigation.

Underreporting is one of the most significant challenges in pharmacovigilance worldwide. Here is a detailed description covering what it is, its causes, how to fix it, and relevant examples.

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.