Workshop Estratégia Regulatória
05 de Abril de 2018 - Sindusfarma - São Paulo/SP
Anvisa has been training technically and investing in the qualification of its technicians year by year, which can be visualized in the evolution of the resolutions, guides and technical notes that have been published, besides an increasingly detailed and deep analysis of the data that it composes a registration dossier.
The pharmaceutical industry, following this trend of more complex processes, new technologies and methodologies increasingly specific and robust, needs to invest more and more to follow this evolution.
Effective communication between the regulated and regulatory sectors is the second largest responsible for the success or failure of a registration petition. Understanding the data to be presented and anticipating possible requirements is a challenge, and the biggest responsibility lies with the regulatory area.
If we add in this scenario the new requirements for the management of the drug after approval, we will see that regulatory performance now depends not only on the technical data that the regulatory area receives but also on its capacity to analyze, interpret, translate and correlate all this information, objectively, clearly and in compliance with the complex web of guides and regulations related to the registration dossier.
With this in mind, this workshop has been proposed and structured to support regulatory professionals who wish to prepare for this moment.
Participants had access to technical analysis and strategic guidance tools in the composition of drug registration dossiers, based on current regulations (for new, generic and similar drugs), as well as participating in case studies and open discussions on best practices regulatory frameworks.