Articles tagged with “drug-safety”

An educational guide comparing the EU Risk Management Plan (RMP) vs. the US REMS for drug safety. Learn about key differences in scope, content, and triggers.

A clear comparison of the DSUR vs. the PSUR/PBRER. Understand the distinct purpose, scope, timing, and governance of these key pharmacovigilance safety reports.

An in-depth guide to the ICH E2B(R3) standard for pharmacovigilance. Explore the data structure of ICSRs, electronic reporting rules, and key global systems.

An in-depth analysis of the top pharmacovigilance databases: Oracle Argus, ArisGlobal LifeSphere, and Veeva Vault Safety. Compare features, compliance & costs.

Learn the end-to-end pharmacovigilance process for translating safety signals into drug label updates. This guide explains CCDS and how Vault Signal accelerates

Explore the regulatory process for negotiating an FDA boxed warning on drug labeling, from initial NDA review to post-market Safety Labeling Changes (SLCs).

Learn how the FDA's PLLR replaced old pregnancy categories. This guide explains how to draft clear pregnancy risk summaries for complex biologics with limited d

Explore a structured cascade model for rolling out pharma safety labeling updates to global affiliates, ensuring regulatory compliance and sub-90-day implementa

Learn the key differences between an Adverse Event (AE), Serious AE (SAE), and SUSAR. This guide clarifies definitions, causality, and expedited reporting timel

Learn about the modern pharmacovigilance tech landscape. This guide explains key systems, AI/ML for signal detection, PV automation, and data standards for drug

Understand the ICH M7 guideline for assessing and controlling mutagenic impurities in pharmaceuticals using in silico (Q)SAR software, TTC, and risk-based metho

This article provides a technical overview of pharmacovigilance software, detailing core functions, regulatory compliance, and a comparison of leading platforms.

An overview of AI agents in pharmacovigilance (PV), detailing their application in processing safety data and managing the increasing volume of ICSRs.

Learn about the FDA Adverse Event Reporting System (FAERS), a database for post-marketing drug safety surveillance and detecting new adverse event signals.

An overview of AI in pharmacovigilance, detailing its use in signal detection, case processing automation, and managing regulatory & ethical considerations.

Comprehensive overview of how computer vision technologies are revolutionizing pharmaceutical quality control processes, from tablet inspection to packaging verification, with real-world implementation examples and ROI analysis.