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ISSN: 2333-9721
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-  2019 

The Complexity of Compliance in Sample Management: A Review of Key Issues Impacting Small

DOI: 10.1177/2472630318817735

Keywords: compliance,material transfer agreement,Nagoya,biological licensing,shipping

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Abstract:

The discovery of new medicines has become increasingly more challenging and requires significant collaboration between pharma, biotech, academia, and technology to be successful. These partnerships necessitate the streamlined exchange of samples while adhering to the increasingly complex set of legal and proprietary restrictions, government legislation, and ethical considerations associated with samples. There is a significant volume of literature published on clinical sample compliance but little describing compliance aspects of discovery sample management. This paper describes some of the key compliance activities and challenges and shares GlaxoSmithKline’s experiences and current practices

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