title: A knowledge management system for new drug submission by pharma-industries.
abstract: The pharma-industries are facing a number of crucial business issues to improve operational excellence in product time-to-market and wide regulatory compliance. These organizations own, produce, and manipulate a lot of knowledge. The new regulations by Health Authorities (HA) to pharma-industries should make the content and format of new drug application uniform worldwide. In this paper we suggest a novel approach of a pharma-industry to capture, process, and transmit clinical data electronically. The approach begins with an analysis of the knowledge generation points, some of them being outside the company. Implementations are grounded on the use of a de facto standard platform being Microsoft, having acceptable cost levels. The proposed infrastructure is integrated into existing company environment and technological platform, minimizing cost and risks, but improving efficiency and efficacy of new drug dossier compilation.
authors.affiliation: Dipartimento di Bioingegneria, Politecnico di Milano, Piazza L. da Vinci 32, I-20133 Milan, Italy. francesco.pinciroli@polimi.it
authors.forename: Francesco
authors.initials: F
authors.lastname: Pinciroli
authors.forename: Sara
authors.initials: S
authors.lastname: Mottadelli
authors.forename: Maurizio
authors.initials: M
authors.lastname: Vinci
authors.forename: Luigi
authors.initials: L
authors.lastname: Fabbro
authors.forename: Klas
authors.initials: K
authors.lastname: Gothager
mesh_terms: D017277:Drug Approval / Q000458:organization & administration*; D004345:Drug Industry; D019451:Information Management; D012984:Software; D012985:Software Design