Producers versus regulators? an enquiry into pharmaceutical quality information systems

Mark Mills, Philip Scott

Research output: Contribution to conferencePaperpeer-review

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Abstract

Given rising costs and declining R&D productivity, the pharmaceutical industry needs information systems and processes that contribute to business efficiency and cost reduction without compromising fundamental quality and safety principles. This study investigated quality information systems in the pharmaceutical industry and the relationship between the industry and its regulators. The data demonstrated a risk-based approach to information management and a quality-by-design philosophy in the industry, aiming to satisfy the needs of product regulators, optimise manufacturing process efficiencies, and give patients reliably consistent medicines and devices. The data also revealed a problematic perception of regulatory oversight, with highly significant correlations between level of regulator contact and ‘difficulty’ with regulators (r=0.92) and between difficulty with regulators and delays in IT implementations (r=0.87).We propose that emerging trends in standards-based interoperability offer a new paradigm for the industry and its regulators.
Original languageEnglish
Publication statusPublished - Mar 2012
EventUK Academy of Information Systems - Oxford, United Kingdom
Duration: 27 Mar 201228 Mar 2012

Conference

ConferenceUK Academy of Information Systems
Country/TerritoryUnited Kingdom
CityOxford
Period27/03/1228/03/12

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