12th International Conference and Exhibition on Pharmacovigilance & Drug Safety
Food and Drug Law, Brazil
Title: Legal tools for risk management in the global regulatory affairs framework
Biography: Eliana Silva de Moraes
A medicinal product is authorised on the basis of the benefit-risk judged at the time of approval process registration. Besides, pharmaceutical companies need to deal regularly with necessary measures to mitigate risks and preserve the benefits of the product specially when working in a global market. Transforming risk management concepts into regulatory actions is crucial for a successful pharmaceutical projects. This presentation will cover the recent and relevant laws, international standards, and regulations contributing to the achievement of the essential tools to treat risks and evaluate the pharmaceutical products benefits; comprehensive survey of legal benefit-risk definition; evaluation and control of the registration approval process globally. Identification and analysis of different tools in the legislation to controls the risk; critereas for risk evaluation such as clinical trial, pharmacovigilance and other important procedures.