Biobanks as Producers of Reference Materials

Author:

Betsou Fay

Publisher

Springer International Publishing

Reference38 articles.

1. International Organization for Standardization Conformity Assessment General Requirements for the Competence of Reference Material Producers. ISO 17034:2016

2. European Medicines Agency Committee for Medicinal Products for Human Use (2010) Reflection paper on co-development of pharmacogenomic biomarkers and assays in the context of drug development. EMA/CHMP/641298/2008

3. European Commission (2012) Proposal for a regulation of the European Parliament and of the council on in vitro diagnostic medical devices. COM 2012/0267

4. Betsou F, Lehmann S, Ashton G et al (2010) Standard preanalytical coding for biospecimens: defining the sample PREanalytical code. Cancer Epidemiol Biomark Prev 19:1004–1011

5. Moore HM, Kelly AB, Jewell SD et al (2011) Biospecimen reporting for improved study quality. Biopreserv Biobank 9:57–70

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