Evaluation of the effectiveness of drug risk-minimisation measures is mandatory for both risk evaluation and mitigation strategies (REMS) in the United States and risk management plans in the European Union (EU-RMPs). Such evaluations aim to assess the impact of risk-minimisation measures on the knowledge, attitudes or behaviours of healthcare professionals or patients, the incidence of safety concerns, and their impact on the overall benefit-risk balance. Although many effectiveness evaluation models and methods are available, regulatory guidance and policy are still evolving. This paper considers evaluation strategies, challenges in evaluating risk minimisation post-authorisation, possible outcome measures and their interpretation, and potential emerging regulatory policy issues. Particular challenges include appropriate data collection, perceived and real burdens of performing evaluation on clinical practice, lack of comparators and benchmarking, and uncertainty about the best outcome measures.
This book comprehensively reviews therapeutic risk management, a fi eld that has expanded rapidly over the past decade. Although risk management has always existed for medicines, the introduction of new regulations has radically changed, formalised and structured the fi eld. Risk management has become a critical factor for the success of a medicinal product, so it is essential for participants in the pharmaceutical industry and regulatory agencies to have an appropriate level of understanding. This book explains how to perform risk management effectively throughout a product's life-cycle, whether assessing benefi t-risk balance, developing risk management plans, implementing risk management activities, or interacting with regulatory authorities.
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