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 EudraVigilance and E2B(R3) Skills Still Matter in 2026
It is easy to assume that modern pharmacovigilance careers are moving entirely toward AI, automation, and advanced analytics. But EMA’s 2026 EudraVigilance...
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CVMP March 2026 Meeting Highlights Keep Veterinary Safety on the Radar
EMA published meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) for 10–12 March 2026. The agency says the meeting was followed by...
EMA Pushes ESMP Training as Shortage Reporting Matures
EMA’s “What’s new” page lists a new event for European Shortages Monitoring Platform (ESMP) training on readable IDs and general updates for industry dated 20...
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...
MHRA Strengthens Warnings for Gabapentinoids, Benzodiazepines and Z-Drugs
MHRA has reviewed how risk information is communicated for gabapentinoids, benzodiazepines, and z-drugs and concluded that warnings on these medicines need to...
What the FDA’s New AEMS Signal Page Means for Pharmacovigilance Teams
The FDA’s new Adverse Event Monitoring System (AEMS) includes a page dedicated to new safety information or potential signals of serious risks identified...