Meet Inspiring Speakers and Experts at our 3000+ Global Conference Series LLC LTD Events with over 1000+ Conferences, 1000+ Symposiums
and 1000+ Workshops on Medical, Pharma, Engineering, Science, Technology and Business.

Explore and learn more about Conference Series LLC LTD : World’s leading Event Organizer

Back

12th International Conference and Exhibition on Pharmacovigilance & Drug Safety

Rome, UK

Eliana Silva de Moraes

Eliana Silva de Moraes

Food and Drug Law, Brazil

Title: Legal tools for risk management in the global regulatory affairs framework

Biography

Biography: Eliana Silva de Moraes

Abstract

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 trialpharmacovigilance and other important procedures.