This paper explores the possibilities of automating the electronic submission of applications for marketing authorizations of medicines. The documentation required by government regulatory agencies across the world is complex and the amount of information supplied by pharmaceuticals is large and multifaceted. Current software support is limited and offers only a technical validation mechanism of linking PDF files, which constitute a Common Technical Document (CTD), to the navigation structure available in XML. It fails to check the validity of the content of the eCTD files and there is no automation in locating PDF files according to their contents. We propose a solution based on ontologies and which helps to eliminate errors when submitting the eCTD and to guarantee its correct content and navigational structure. The implementation is based on an OWL ontology, which uses OWL 2.0 modeling constructs, their constraints and restrictions, plus SWRL reasoning rules.
|Book title||Proceedings of the Twelfth SDPS Transdisciplinary Conference-Workshop on Integrated Systems, Design & Process Science. Montgomery, Alabama, The Informatics Institute, Auburn University at Montgomery, November 1-5, 2009|