Risk Management for the 21st Century: Current Status and Future Needs

Rania Mouchantaf (), Doris Auth, Yola Moride, June Raine, Soon Young Han and Meredith Y. Smith
Additional contact information
Rania Mouchantaf: Marketed Health Products Directorate
Doris Auth: Office of Surveillance and Epidemiology
Yola Moride: Université de Montréal
June Raine: Medicines and Healthcare products Regulatory Agency
Soon Young Han: Korea Institute of Drug Safety and Risk Management
Meredith Y. Smith: Alexion Pharmaceuticals, Inc.

Drug Safety, 2021, vol. 44, issue 4, No 4, 409-419

Abstract: Abstract Global adoption of risk management principles outlined in the International Conference on Harmonisation (ICH) E2E guideline and the Council for International Organizations of Medical Sciences (CIOMS) Working Group VI guidance introduced greater proactivity and consistency into the practice of pharmacovigilance and benefit–risk management throughout the lifecycle of a drug. However, following the release of these guidelines there have been important advances in the science and practice of risk minimisation itself, especially in terms of how risk minimisation measures (RMMs) are designed, implemented, disseminated and evaluated for effectiveness in real-world healthcare settings. In this article, we describe how the field of design, implementation, dissemination and evaluation of RMMs has advanced in recent years while highlighting current areas of challenge and possible solutions. Where possible we cite global examples to demonstrate how evidence-based approaches have informed the development of RMMs. In this context, while taking into consideration local healthcare system policies and national legislations, we conclude with a call for a global effort to harmonise certain areas that focus on, but are not limited to, standardising certain terms and definitions, consistent application of robust methodologies, and outline of best practices for risk minimisation design, implementation, and dissemination.

Date: 2021
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DOI: 10.1007/s40264-020-01033-z

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