Developing a database for automating regulatory affairs in the pharmaceutical industry

Slevin, Lindi, Shojanoori, Reza and Juric, Radmila (2005) Developing a database for automating regulatory affairs in the pharmaceutical industry. Transactions of the SDPS / Journal of Integrated Design and Process Science, 9 (4). pp. 1-11. ISSN 1092-0617


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The complex procedure of processing the marketing authorization of medicinal product licenses is a challenging task for government health authorities and the pharmaceutical industry across the world. Regulatory requirements have diverged significantly, and each country has its own regulations and procedures for marketing authorizations. The automation of and adequate software support for such procedures are critical factors that can improve the efficiency of regulatory authorities. In this paper we report on the design and implementation of a database whose role is to (a) support the automation of marketing authorization procedures, (b) address the interoperability of such procedures across the world, and (c) be reusable across a family of related applications. Our database is implemented in Oracle8i, and a distributed and component-based application has been built upon it using the J2EE technology.

Item Type: Article
Uncontrolled Keywords: Marketing authorization, licensing application, submission and evaluation, software interoperability, EJB
Subjects: University of Westminster > Science and Technology > Electronics and Computer Science, School of (No longer in use)
Depositing User: Miss Nina Watts
Date Deposited: 06 Jul 2006
Last Modified: 11 Aug 2010 14:31

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