img

Title: Global legal tools for pharmacovigilance and risk control

Eliana Silva De Moraes

The Brazilian Regulatory Affairs Society – ABPVS in Europe, Brazil

Biography

Eliana Silva de Moraes has her expertise in food and drug law. Twenty six years experience in international food and drug law: pharmaceutical, medical device, cosmetic, food sector. Help companies to gain presence in markets of Latin America and Europe. She has an active participation in the Global harmonization process through the organizations that she represents, ABPVS. Played an active role in setting up Brazil’s Public Health Regulator (ANVISA). Partner at Silva de Moraes. Member of the Brazilian Bar Association and Portugal Bar Association. Speaks Portuguese, English, French and Spanish.

Abstract

For those who works in the pharmaceutical sector knows that doing business globally is a challenge. The regulatory affairs profdessional needs to have a broadly view of the current trends such as risk management, pharmacovigilance, misleading, etc.
         Due the divergence between regulators values  of different countries and the need to meet common standars and develop efficient tools to optimize the regulatory dialogue, especially regarding risk assessment and the pharmacovigilance process, it is mandatory understand and identify common legal elements of the international regulatory enviroment. The presentation will cover the recent and relevants laws, international standards, and regulations contributing to a achievement of the essential tools to treat risks and evaluate the products benefits.
         During the session, the panel on pharmacovigillance will highlight current challenges, opportunities and developements. The discussion also will creating possibilities for imporved sharing of knowledge, information and resources to supor the participant to gathered the global best perspectives in pharmacovigilance regulation and practices.
Audience take away:
• Participants will be able to lead differents regulatory systems
• Develop better tools and capacity for effective risk/benefit assessment
• Increase measures to ensure consumers are aware of the dangers
• Gives an opportunity for participants to adresses topics of common interest which have emerge during the presentation and discussion