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...
No Results Found
The page you requested could not be found. Try refining your search, or use the navigation above to locate the post.
EMA’s PMS FAQs Show Where Product Data Friction Still Exists
EMA’s Product Management Service FAQs, updated in January 2026, collect questions raised during PMS events and are intended to complement those sessions. EMA...
MHRA’s National Assessment Procedure Update: Why It Matters in 2026
MHRA updated its National assessment procedure for medicines guidance on 24 February 2026, setting out the agency’s UK national route for marketing...
FDA Warning Letter to Novo Nordisk: What the March 2026 Action Signals for PV Compliance
On 5 March 2026, the FDA issued a warning letter to Novo Nordisk Inc. describing objectionable conditions observed during an inspection that reviewed the...
EMA’s PRAC Recommends Withdrawal of Levamisole Medicines: A Reminder of How Safety Reviews Can End
In February 2026, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) concluded its safety review of levamisole-containing...
What PRAC Safety Signals Mean for Pharmacovigilance Teams
For pharmacovigilance professionals working in or around the European regulatory environment, PRAC safety signals are among the most important routine outputs...
PAHO Calls for Stronger Pharmacovigilance After Reports of GLP-1 Misuse
The Pan American Health Organization has called for strengthened pharmacovigilance following reports of misuse involving GLP-1 medicines indicated for...
UK Clinical Trial Rules Change on 28 April 2026: What PV Teams Should Prepare For
The UK’s updated clinical trials regulations will come into force on 28 April 2026, marking an important date for sponsors, researchers, and pharmacovigilance...
FDA Launches AEMS: Why the New Adverse Event Monitoring System Matters for Pharmacovigilance
The U.S. Food and Drug Administration has launched the FDA Adverse Event Monitoring System (AEMS), a new unified platform designed to modernize how adverse...