by Admin | Mar 16, 2026 | Inspections & Compliance
EMA says it provides EudraVigilance training to support stakeholders in meeting their pharmacovigilance obligations and to ensure users understand system functions and submit high-quality data. EMA also states that at least one user per organisation should be trained...
by Admin | Mar 16, 2026 | Inspections & Compliance
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 regulatory framework, the changes still have practical implications for some UK-authorised medicines,...
by Admin | Mar 16, 2026 | AI & Digital PV
FDA says MedWatch is its program for reporting serious reactions, product quality problems, therapeutic inequivalence or failure, and product-use errors for human medical products, including drugs, biologics, devices, dietary supplements, infant formula, and...
by Admin | Mar 15, 2026 | AI & Digital PV
FDA says that when a potential signal of a serious risk is identified from AEMS data, it will be posted in the required quarterly report in the quarter in which it is first identified. FDA also says that if additional safety information later develops around a...
by Admin | Mar 15, 2026 | AI & Digital PV
FDA says its new Adverse Event Monitoring System, or AEMS, is designed as a centralized platform not just for adverse event reports, but also for consumer complaints, regulatory misconduct reports, and whistleblower submissions across FDA centers. The agency says this...
