Category: Drug safety and pharmacovigilance

In this comprehensive article, you’ll discover who the key term by subjects in clinical studies. Let’s dive in and explore.

This article explains the importance of adverse event reporting to how to further process for effective submission reports to regulatory authorities.

This blog provides a clear and concise overview of pharmacovigilance system master file the essential components, regulatory expectations, maintenance practices.

In This blog, You’ll discover: Introduction In any field of work, meaningful contributions are essential to achieving success—and pharmacovigilance is no exception. Contributors and collaborators play a crucial role in strengthening pharmacovigilance activities, ultimately helping to ensure public safety through the safe use of medicines. In this article, we’ll explore who these contributors are, what…

Welcome to our informative article, where we unravel the concept of the Investigational Brochure (IB). In this comprehensive piece, we aim to provide a clear understanding of what an IB is, its purpose, significance, and the important components it comprises.

This blog features: Introduction This blog provides a clear understanding of why pharmacovigilance is a crucial aspect of clinical trials throughout the entire product life cycle. Although pharmacovigilance and clinical trials are distinct domains, both contribute significantly to ensuring drug safety. Pharmacovigilance plays a continuous role from development through post-marketing, safeguarding public health at every…

This blog includes: Introduction In the context of data collection, multiple report types contribute to the generation of safety reports. However, one source stands out for being less organized and accumulating large data, i.e, spontaneous reports. It significantly impacts the risk and benefit profile of drug safety. This section will explore this reporting system and…