DEVELOPING A DATABASE FOR AUTOMATING REGULATORY AFFAIRS IN THE PHARMACEUTICAL INDUSTRY

Article type: Research Article

Authors: Slevin, Lindi | Shojanoori, Reza | Juric, Radmila

Affiliations: Department of Information Systems, Cavendish School of Computer Science, University of Westminster, London, UK

Abstract: 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.

Keywords: marketing authorization, licensing application, submission and evaluation, software interoperability, EJB

Journal: Journal of Integrated Design & Process Science, vol. 9, no. 4, pp. 1-11, 2005