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Risk Management and Minimization

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Evidence-Based Pharmacovigilance

Part of the book series: Methods in Pharmacology and Toxicology ((MIPT))

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Abstract

Therapeutic risk management aims to improve patient safety by assessing and monitoring the risks, and by developing risk minimization interventions to reduce or mitigate such risks while maximizing benefits. Throughout the lifecycle of drug development, risk management broadly includes the surveillance and detection of previously unknown risks, evaluation of potential risks or key safety concerns, as well as minimization or mitigation of identified risks. Assessment of effectiveness of risk minimization is methodologically challenging in the absence of an “unexposed” population and clear outcome definitions. Of concern also is the undue burden for healthcare professionals and healthcare systems that may be generated by risk minimization, which remains inadequately explored to date. A framework for the different components of risk management and minimization, as well as practical examples for the evaluation of effectiveness of risk minimization interventions, are presented in this chapter.

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Author information

Authors and Affiliations

  1. Faculty of Pharmacy, Université de Montréal, Montréal, QC, Canada

    Yola Moride

Authors
  1. Yola Moride
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Correspondence to Yola Moride .

Editor information

Editors and Affiliations

  1. Epidemiology Group Lead, Analytics, Worldwide Safety and Regulatory, Tadworth, Surrey, UK

    Andrew Bate

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Moride, Y. (2018). Risk Management and Minimization. In: Bate, A. (eds) Evidence-Based Pharmacovigilance. Methods in Pharmacology and Toxicology. Humana Press, New York, NY. https://doi.org/10.1007/978-1-4939-8818-1_12

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  • DOI: https://doi.org/10.1007/978-1-4939-8818-1_12

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  • Publisher Name: Humana Press, New York, NY

  • Print ISBN: 978-1-4939-8816-7

  • Online ISBN: 978-1-4939-8818-1

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