Gestiòn de la I+D en el ámbito de la industria farmacéutica

Zusammenfassung

GESTIÓN DE LA I+D+I EN EL ÁMBITO DE LA INDUSTRIA FARMACÉUTICA #RESUMEN: The launch of innovative medicine, synonymous of a pharmaceutical and biomedical sector*'s competitiveness, becomes a more difficult and complex process with time. This fact convinces us of the need for a management system part of a company's strategy, which includes business intelligence, knowledge management, different Quality Management Systems (GLP, GMP, GCP) and regulatory affairs, being the main objective the continuos improvement. (tqm). In 2002, a Spanish family of standards (UNE 16600X: 2002EX) was created which set up requirements of a general R&d Management System. The objective of this work was to demostrate the viability of these standards in the pharmaceutical sector First, we have made a comparative analysis of the different Quality Management Systems versus UNE 166002:2002EX. As a result, we obtained the conformity and complementarity percentages of these systems. secondly, using these results and making a thorough analysis of management tools, a R&d management system model has been developed, which contributes new elements such as a R&d management Unit, processes management, a System of Strategic Intelligence, metrics and measuring, analysis and improvement activities. All of these elements, which assure the Quality of the R&d process and the product ufe cycle, are responsible for the success of new innovative medicines. Finally, we propose the certification and acreditation of the R&d Management System as a tool to obtain the direct and indirect incentives which guarantee an efficient R&d, and the need to add a fifth line of action called " R&d Management" to the technological Platforms of Innovative Medicines