PV Watch Daily Blog
Fresh reporting, analysis, and expert insight on drug safety, regulatory developments, safety signals, inspections, AI in pharmacovigilance, and career trends.
Why E2B(R3) and EVWEB Skills Still Open Doors in 2026
EMA’s 2026 hands-on EudraVigilance training says participants should be able to apply ISO/ICH E2B(R3) rules to spontaneous and follow-up reports, amendment...
Beyond FAERS: How FDA’s AEMS Is Expanding Digital Safety Surveillance
The FDA’s Adverse Event Monitoring System (AEMS) is easy to describe as a modernization of public safety-data access, but that understates what the agency is...
FDA’s Action on Xylazine Imports Shows How Safety Oversight Extends Beyond Approved Drugs
FDA announced action to restrict unlawful imports of xylazine active pharmaceutical ingredients and finished dosage-form drug products into the United States....
PRAC Reviewed 140 PSUR Recommendations in January 2026: What That Tells Us
EMA’s January 2026 PRAC statistics show 140 PSUR recommendations, along with reviews of risk management plans and study protocols and results. That is a...
Why AI Governance Is Becoming a Career Advantage in Pharmacovigilance
There is growing excitement around AI in pharmacovigilance, but one career lesson is becoming clearer: in regulated environments, tool familiarity is not...
Why EudraVigilance Training Is a Compliance Control, Not Just Admin
EMA’s EudraVigilance ecosystem is often discussed in technical terms — electronic reporting, ICSR formats, EVWEB access, registration — but there is an...
UK Trial Safety Reporting in 2026: What Inspection-Ready Teams Should Get Right
The UK’s updated clinical-trial framework is moving from preparation to implementation, and that makes safety-event reporting discipline more important than...
FDA’s 10 Good AI Practice Principles: What They Mean for PV Teams
The FDA’s Guiding Principles of Good AI Practice in Drug Development, published on 14 January 2026, may not have been written specifically for...
Beyond FAERS: How FDA’s AEMS Is Expanding Digital Safety Surveillance
The FDA’s Adverse Event Monitoring System (AEMS) is easy to describe as a modernization of public safety-data access, but that understates what the agency is...
Patent Expirations Are Pushing Biopharma Toward a Tougher 2026 — Why PV Teams Should Pay Attention
A new Fierce Pharma report says the biopharma industry is heading into a more difficult 2026 as major companies confront a mix of patent expirations, slowing...