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...
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...
Global Watch Weekly: MHRA, EMA Shortages and Veterinary Developments
MHRA approved deuruxolitinib for severe alopecia areata in adults and explicitly said it would continue to keep the medicine’s safety and effectiveness under...
Week in PV: FDA B6 Warning, GLP-1 Label Change and PRAC Updates
This week’s major U.S. developments include FDA’s requirement for a vitamin B6 deficiency and seizure warning on carbidopa/levodopa products and the agency’s...
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...
Why AI Governance Is Becoming a Differentiator in PV Careers
FDA’s 2026 Good AI Practice principles emphasize context of use, multidisciplinary expertise, data governance, lifecycle management, and clear essential...
A Missing PIL Warning, a GPvP Inspection, and a Bigger Compliance Lesson
MHRA’s December 2025 defect notification for certain amitriptyline tablets says the patient information leaflet did not contain all required safety...
Why EudraVigilance Training Is a Compliance Requirement in Practice
EMA says it provides EudraVigilance training to support stakeholders in meeting their pharmacovigilance obligations and to ensure users understand system...
What the Amended CIR 520/2012 Means for Some UK-Authorised Products
MHRA says that amendments to the EU Commission Implementing Regulation 520/2012 took effect on 12 February 2026 and, although the UK operates an independent...
Why MedWatch Still Matters in the Age of Digital Safety Platforms
FDA says MedWatch is its program for reporting serious reactions, product quality problems, therapeutic inequivalence or failure, and product-use errors for...