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59459 1490631916HCLSReviewIrelandMarch2017.pdf
Energy Boardroom

Risk Evaluation and Mitigation Strategy (REMS) in Oncology from 2008 to Date

27.06.2014 / Thomson Reuters Blog

Risk Management is defined in FDA Guidance for Industry: Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment as an iterative process of: assessing a product’s benefit-risk balance, developing and implementing tools to minimize its risks while preserving its benefits, evaluating tool effectiveness and reassessing the benefit-risk balance, and making adjustments, as appropriate, to the risk minimization tools […]

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