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 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
GUIDES: Medical Device Post-Market Safety Reporting How to Report Medical Device Adverse EventsA Regional Compliance Guide: US, EU, Canada, Japan, and Australia Adverse event reporting for medical devices is a mandatory post-market safety obl
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
