Regulatory sanctions for ethically relevant GCP violations

Bernabe, RD; van Thiel, GJMW; Breekveldt, NS; Gispen, CC; van Delden, JJM

Bernabe, RD (reprint author), Univ Oslo, Inst Hlth & Soc, Ctr Med Eth, Oslo, Norway.

DRUG DISCOVERY TODAY, 2019; 24 (11): 2116

Abstract

Although EU inspectors and clinical assessors are mandated to identify and act upon ethical issues, regulators lack guidance on how this can be done. ......

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