The full-time staff of our company's adverse drug reaction report participated in the training of "direct reporting adverse reaction system"

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Datetime: 2018-05-30 10:20


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On May 15, 2018, the National Adverse Reaction Monitoring Center held the "Training Course on Implementing the Direct Report of Adverse System for Drug Marketing License Holders" in Nanjing. More than 600 people from institutions and units from all over the country participated, and our company's full-time staff of adverse reactions Also participated in this study and training.

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The main content of this learning and training covers the evolution of the ADR management system directly reported by drug marketing license holders and the domestic and international situation, including the function demonstration of ADR direct reporting system, pharmacovigilance plan, clinical safety data management, electronic transmission data elements of individual safety reports, risk benefit assessment report, collection and reporting guidelines of individual adverse drug reactions, discovery and risk control of adverse drug event aggregation signals, adverse drug reaction reports and monitoring and inspection points analysis and other 13 items.

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