Implementação do programa de inteligência e estratégia regulatória nos Laboratórios Farmacêuticos Oficiais (LFO).

Abstract

The high complexity of the regulation of products subject to sanitary surveillance in Brazil, its rapid evolution and strategic importance are factors that justify the use of tools that help in the systematic monitoring of this highly regulated scenario in order to guarantee regulatory compliance. This work indicates the use of Regulatory Intelligence, as it is a tool capable of guaranteeing regulatory suitability by creating strategies based on the outlining of risks and opportunities, in order to maintain the life cycle of products as well as assist in the registration of products subject to health surveillance. Therefore, this dissertation has the general objective of mapping an active data search methodology and the implementation of the intelligence program and regulatory strategy, providing predictability of trends to support decision-making, in addition to preparing a manual to contribute to the implementation of the strategy. regulation in Official Pharmaceutical Laboratories. Activities in Regulatory Affairs were mapped and the search channels were duly identified and registered to capture relevant information for the institution. All this mapping was critically analyzed with the information obtained in order to generate knowledge for the organization and propose opportunities of improvements through an impact report to High Administration. Considering that the knowledge communication stage is essential for the consolidation of Regulatory Intelligence, two formal documents were established in Regulatory Affairs, namely: Newsletter and Regulatory Impact Mapping Report. With regard to the Manual, a guidance document was made available with step-by-step instructions for using the tool, in addition to presenting a procedure model for actively searching for information. Among the results obtained for the Pharmaceutical Laboratory of the Navy, the following stand out: the development of the ability to organize information, promotion of the creation of a continuous cycle of new knowledge that was used strategically, made processes more robust, increased capital institutional, reduced the time for submitting processes to the regulatory body and improved technical documentation. It should be noted that the manual innovates by bringing a low-cost technical procedure that streamlines processes in Regulatory Affairs and, as a consequence, offers robustness to work methods. This document was constructed based on practical experience at the Navy Pharmaceutical Laboratory and must be continuously improved.