Articles tagged with “drug-safety”

Examine the architectural design and compliance framework for AI governance in pharmacovigilance, including FDA and EU regulatory guidelines for drug safety.

An analysis of AI governance in pharmacovigilance, detailing how the EU AI Act and GxP regulations impact drug safety platforms like Oracle Argus and Veeva.

Analyze when biotechs need pharmacovigilance software. Covers FDA safety database requirements, compliance risks, and solution options for clinical trials.

Learn how AI automates adverse event detection in pharmacovigilance. This guide covers GVP compliance, NLP methods, and validation standards for safety data.

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.

Learn the end-to-end pharmacovigilance process for translating safety signals into drug label updates. Covers CCDS, Vault Signal, EU Regulation 2025/1466, FDA AEMS, and how modern PV platforms accelerate the safety-to-label relay. Updated April 2026.

Explore the regulatory process for negotiating an FDA boxed warning on drug labeling, from initial NDA review to post-market Safety Labeling Changes (SLCs), with 2025-2026 case studies including HRT warning removal, Elevidys, Carvykti, and COVID vaccine labeling debates.

Learn how the FDA's PLLR replaced old pregnancy categories. Updated 2026 guide on drafting clear pregnancy risk summaries for biologics, with ICH E21, IMPACT trial, and PIANO registry data.

Explore a structured cascade model for rolling out pharma safety labeling updates to global affiliates, covering FDA 505(o)(4) guidance, EMA variations framework, AI-powered PV tools, and sub-90-day implementation strategies.

Learn the key differences between an Adverse Event (AE), Serious AE (SAE), and SUSAR. Updated for 2026 with ICH E6(R3), EU CTR 536/2014 CTIS, FDA Dec 2025 guidances, and ICH E2B(R3) mandate. Covers definitions, causality, and expedited reporting timelines.

Updated 2026 guide to pharmacovigilance technology covering GenAI/LLMs in PV, AI-powered case processing, signal detection, FDA-EMA AI guidance, and data standards for drug safety

Updated 2026 guide to ICH M7 mutagenic impurity assessment software including Derek Nexus 6.5, Sarah Nexus 5.1, Leadscope 2025.0, OECD QSAR Toolbox 4.8, AmesNet deep learning, and nitrosamine regulatory developments.

Updated for 2026, this article provides a technical overview of pharmacovigilance software, detailing core functions, regulatory compliance, agentic AI developments, and a comparison of leading platforms including Oracle Argus, ArisGlobal LifeSphere, Veeva Vault Safety, and more.

An overview of AI agents in pharmacovigilance (PV), covering agentic AI, generative AI, and ML applications in safety data processing, ICSR management, and signal detection, with updates on the CIOMS WG XIV final report, FDA's Elsa tool, and EU AI Act requirements.

Learn about the FDA Adverse Event Reporting System (FAERS), now updated in real time with over 31 million reports, for post-marketing drug safety surveillance, signal detection, and AI-enhanced pharmacovigilance.

A comprehensive overview of AI in pharmacovigilance (updated Feb 2026), covering agentic AI, GenAI-driven case processing, signal detection, CIOMS WG XIV framework, FDA/EMA joint principles, EU AI Act implications, and the latest industry platforms.

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.