A Pharmacovigilance Signaling System Based on FDA Regulatory Action and Post-Marketing Adverse Event ReportsProgressive Multifocal LeukoencephalopathyReporting Odds RatioLabel ChangeDrug PairNational Drug File Reference TerminologyINTRODUCTION: Many serious drug adverse events (AEs) only manifest well after ...
A decade of safety-related regulatory action in the Netherlands: a retrospective analysis of direct healthcare professional communications from 1999 to 2009. ... S Piening,KC Reber,JE Wieringa,... - Meeting of the International-society-of-pharmacovigilance 被引量: 33发表: 2012年 Impact of Safet...
. Other requirements are experience in research and regulatory veterinary medicine including interaction with governmental agencies, experience with pharmacovigilance requirements in the US and Canada, experience in Pharmaceutical Manufacturing and experience in assembling product dossiers for submission to ...
In this context, the safety of all centrally registered drugs is closely monitored by the EMA through a new committee, the Pharmacovigilance Risk Assessment... AF Donneau,JY Reginster - 《Osteoporosis International》 被引量: 18发表: 2014年 Medication Errors: New EU Good Practice Guide on Risk...
Global regulatory confluence and additional effort toward mutual recognition significantly increased throughout the pandemic, with regulatory agencies forging new communication pathways for sharing of pharmacovigilance information. Although the FDA did not necessarily witness a significant increase in drug shortage...
Global regulatory confluence and additional effort toward mutual recognition significantly increased throughout the pandemic, with regulatory agencies forging new communication pathways for sharing of pharmacovigilance information. Although the FDA did not necessarily witness a significant increase in drug shortag...
Currently, the ADRs are coded with the MedDRA terminology =-=[1]-=- (Medical Dictionary for Drug Regulatory Activities). For the analysis of these databases and the signal detection, traditional pharmacovigilance methods [23] are exploited. They are currently supplem......