by Admin | Mar 22, 2026 | AI & Digital PV
EMA has scheduled a CTIS sponsor end-user training programme for 8–11 June 2026. The event listing places the training firmly within the live operational environment for European clinical trials. That matters because CTIS competence is increasingly relevant for...
by Admin | Mar 22, 2026 | AI & Digital PV
EMA’s Product Management Service FAQs, updated in January 2026, collect questions raised during PMS events and are intended to complement those sessions. EMA notes that the FAQs should not be treated as a binding commitment, but the document still shows where users...
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...
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,...
