Pharmacovigilance (PV) is the science and practice of monitoring drug safety. It focuses on identifying, assessing, and preventing adverse drug reactions (ADRs) and other drug-related problems. A key part of PV is reporting. Reports are how informati
Drug Safety and Pharmacovigilance: A Complete Guide for Healthcare and Industry Professionals
Drug safety has always been at the heart of healthcare. Every treatment, no matter how promising, carries some level of risk. This is why the science and practice of pharmacovigilance (PV) exist. PV is more than a regulatory requirement, it is the on
How to Report Medical Device Adverse Events: A Regional Compliance Guide (US, EU, Canada, Japan, Australia)
Medical device safety depends on fast and accurate reporting of adverse events, especially when someone is harmed or nearly harmed while using a device. This guide explains how manufacturers, importers, and distributors must report these events in ma
How to Prioritize Safety Signals Using a Risk-Based Approach
Safety signals are early signs that a drug, device, or treatment may be causing harm. These signals come from many places, like clinical trials, post-market surveillance, and patient reports. With so much data coming in, it can be hard to know what t