by Admin | Mar 15, 2026 | AI & Digital PV
FDA’s January 2026 “Guiding Principles of Good AI Practice in Drug Development” lays out ten expectations for regulated AI, including human-centric design, a risk-based approach, clear context of use, multidisciplinary expertise, data governance, lifecycle management,...
by Admin | Mar 14, 2026 | Careers
It is easy to assume that modern pharmacovigilance careers are moving entirely toward AI, automation, and advanced analytics. But EMA’s 2026 EudraVigilance training agenda is a helpful reminder that foundational reporting skills still matter deeply. EMA’s hands-on...
by Admin | Mar 14, 2026 | Careers
There is growing excitement around AI in pharmacovigilance, but one career lesson is becoming clearer: in regulated environments, tool familiarity is not enough. Professionals who understand how to govern AI — how to define context of use, assess risk, document...
by Admin | Mar 14, 2026 | Inspections & Compliance
EMA’s EudraVigilance ecosystem is often discussed in technical terms — electronic reporting, ICSR formats, EVWEB access, registration — but there is an equally important compliance message embedded in how the system is managed. EMA says it offers training to support...
by Admin | Mar 14, 2026 | Inspections & Compliance
The UK’s updated clinical-trial framework is moving from preparation to implementation, and that makes safety-event reporting discipline more important than ever. MHRA guidance on the collection, verification, and reporting of safety events in clinical trials explains...
