Pharmacovigilance Learning Pathway

How to Identify ICSRs in Medical Literature: Step-by-Step Guide for Pharmacovigilance Professionals Literature screening is a major pillar of pharmacovigilance (PV) . It ensures that potential adverse drug reactions reported in scientific publications are captured, evaluated, and reported to regulators. For Marketing Authorization Holders (MAHs), effective literature monitoring is not optional — it is a regulatory obligation.  This process, often referred to as literature screening in pharmacovigilance , is essential for timely safety detection. This guide explains how to identify Individual Case Safety Reports (ICSRs) in literature , based on practical workflow concepts and regulatory expectations, along with real examples and a reviewer checklist.

Importance of Pharmacovigilance in Clinical Trials: Key Safety Activities and Regulatory Requirements Pharmacovigilance (PV) during clinical trials encompasses the science and activities related to the detection, assessment, understanding, and prevention of adverse events and other drug-related problems associated with investigational products.  During clinical development, the safety profile of a new drug continues to evolve; therefore, systematic safety monitoring is essential to protect trial participants and ensure the reliability of clinical data.  Pharmacovigilance activities begin with the first administration of an investigational product in humans and continue throughout all phases of development. Furthermore, clinical trials typically involve limited and selected populations, making continuous safety surveillance critical for the early identification of potential risks.  In accordance with ethical principles such as the Declaration of Helsinki and Good Clinical ...

Expectedness vs Seriousness in Pharmacovigilance: Key Differences with Examples Scenarios 1. Introduction: Why Expectedness and Seriousness Are Often Confused When I first started learning pharmacovigilance, I realized that many beginners — including me — easily get confused between expectedness and seriousness . The confusion happens because both terms are used together when assessing adverse events and deciding regulatory reporting timelines. Often, we assume that if a case is serious, it must automatically be unexpected. Similarly, when we hear that an event is unexpected, we tend to think it must also be serious. However, this is a misconception. In pharmacovigilance, expectedness and seriousness are two separate concepts that serve different purposes. They answer various questions about the same adverse event. Seriousness focuses on the impact on the patient — what actually happened to their health. Expectedness focuses on prior knowledge of the drug — whether this ...

Expectedness in Pharmacovigilance Explained: Definition, Sources, and Practical Examples 📌 Table of Contents 1. Introduction to Expectedness in Pharmacovigilance 2. What Does Expected Mean in Pharmacovigilance? 3. Sources of Expectedness in Pharmacovigilance 4. Step-by-Step Expectedness Assessment Process 5. Expectedness Assessment Examples 6. Common Challenges and Best Practices 7. Conclusion: Why Expectedness Matters Introduction to Expectedness in Pharmacovigilance While learning pharmacovigilance, one of the most important concepts I came across is expectedness. At first, it may sound like a simple term, but in real pharmacovigilance practice, expectedness plays a critical role in how adverse events are classified, reported, and communicated to regulatory authorities. In simple terms, expectedness helps determine whether an adverse event is already known for a drug based on available safety information, or whether it represents a new and unanticipated finding. This assessment has...