by Admin | Mar 16, 2026 | Inspections & Compliance
MHRA’s December 2025 Class 4 Medicines Defect Notification for certain amitriptyline tablets says the patient information leaflet contained out-of-date safety information, including missing warnings on serotonin syndrome and dry eye. The notice also states that the...
by Admin | Mar 16, 2026 | Careers
EMA says the eXtended EudraVigilance Medicinal Product Dictionary, or XEVMPD, supports pharmacovigilance activities in the EU, and it continues to publish 2026 training dates for the system. EMA’s registration guidance also says organisations need notification of...
by Admin | Mar 16, 2026 | Careers
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 and nullification reports, parent-child cases, and clinical-trial SUSAR examples. The agenda also includes EVWEB...
by Admin | Mar 16, 2026 | Careers
FDA’s 2026 Good AI Practice principles emphasize context of use, multidisciplinary expertise, data governance, lifecycle management, and clear essential information. That means the regulator is signaling that successful AI use in life sciences depends not only on...
by Admin | Mar 16, 2026 | Inspections & Compliance
MHRA’s December 2025 defect notification for certain amitriptyline tablets says the patient information leaflet did not contain all required safety information and that the errors were identified following an MHRA Good Pharmacovigilance Practice inspection and further...
