Moving towards a Question-centric approach for regulatory decision-making in the context of drug assessment.
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DOI: 10.1002/cpt.2856
Abstract: The most intuitive question for market access for medicinal products is the benefit/risk (B/R) balance. The B/R assessment can conceptually be divided into sub-questions related to establishing efficacy and safety. There are additional layers to… read more here.
Keywords: approach regulatory; question; pharmacology; assessment ... See more keywords
Risk as an Approach to Regulatory Governance: An Evidence Synthesis and Research Agenda
Sign Up to like & getrecommendations! Published in 2021 at "SAGE Open"
DOI: 10.1177/21582440211032202
Abstract: Governments around the world have begun to develop and implement risk governance and risk-based regulation and are often inspired by the insights from risk studies in doing so. Following these developments, scholars have begun to… read more here.
Keywords: risk; regulatory governance; research; approach regulatory ... See more keywords