Browsing Institutt for helse og samfunn by Author "Van Delden, Johannes JM"

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  • Ethics in clinical trial regulation: ethically relevant issues from EMA inspection reports 
    Bernabe, Rosemarie de la Cruz; van Thiel, GJMW; Breekveldt, NS; Gispen-de Wied, CC; Van Delden, Johannes JM (Journal article / Tidsskriftartikkel / AcceptedVersion; Peer reviewed, 2018)
    Background: Within the EU, regulators are obliged to take ethical issues into consideration during marketing authorization deliberation. The goal of this manuscript is to identify what kinds of ethical issues regulators ...
  • Regulatory sanctions for ethically relevant GCP violations 
    Bernabe, Rosemarie de la Cruz; van Thiel, Ghislaine JMW; Breekveldt, Nancy S; Gispen, Christine C; Van Delden, Johannes JM (Journal article / Tidsskriftartikkel / PublishedVersion; Peer reviewed, 2019)
    Although EU inspectors and clinical assessors are mandated to identify and act upon ethical issues, regulators lack guidance on how this can be done. Hence, we propose a four-step regulatory approach on ethically relevant ...