Browsing Institutt for helse og samfunn by Author "van Thiel, GJMW"

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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 ...