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Challenges of regulatory requirements for patient registries in different countries

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Published in 2019 at "Molecular Genetics and Metabolism"

DOI: 10.1016/j.ymgme.2018.12.188

Abstract: The International Niemann-Pick Disease Registry (INPDR) is a single, rare disease-specific registry collating global Niemann-Pick Disease data. Created by professionals and patients for worldwide use, it collects clinical and patient reported data with separate datasets… read more here.

Keywords: regulatory requirements; registry; challenges regulatory; human research ... See more keywords