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Best Archival Practice in the Regulation of Medicines : Work on the Guidelines for Agencies for Medicinal Products

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Rajh, Arian and Stančić, Hrvoje. (2011). Best Archival Practice in the Regulation of Medicines : Work on the Guidelines for Agencies for Medicinal Products. In: 3rd International Conference "The Future of Information Sciences: INFuture2011 – Information Sciences and e-Society", 9-11 November 2011, Zagreb.

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Abstract

This paper announces the beginning of the work on the standardization of filing of electronic medicinal dossiers in agencies for medicinal products. Medicinal products electronic dossiers have to be preserved for the long-term because of the requirements for protection of patients’ safety and standardization of archiving procedures.

Item Type: Published conference work (Lecture)
Uncontrolled Keywords: common European best archival practice, electronic Common Technical Document, eCTD, Open Archival Information System
Subjects: Information sciences > Archivistics and documentation
Departments: Department of Information Science
Date Deposited: 24 Feb 2017 10:02
Last Modified: 24 Feb 2017 10:02
URI: http://darhiv.ffzg.unizg.hr/id/eprint/8181

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