The Brazilian Pharmacovigilance System

Eliana Silva de Moraes

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Attend this webinar to learn about the Brazilian pharmacovigilance regulation, risk management, the Health Brazilian Constitution Rights. Learn about labeling, safety reports, harmonization process, benefit-risk legal concept, reciprocity, and more.

Why Should You Attend:

This webinar will provide the a broadly information of the Brazilian Regulatory System. This is an opportunity for enhancement your knowledge of the Brazilian regulatory system for pharmacovigilance. This webinar will explore regulation on labeling, safety reports, harmonization process, overview of the benefit-risk legal concept, reciprocity, among others.

Learning Objectives:

  • What is the Brazilian pharmacovigilance legislation?
  • The Company’s regulatory and legal requirements regarding the Brazilian pharmacovigilance system.
  • Understand the pharmacovigilance data obligations concerning the processing of safety information.
  • Benefits-risk assessment
  • Crisis management

Areas Covered in the Webinar:

  • Regulatory Affairs
  • Pharmaceutical
  • Advertisement
  • Risk management
  • Documentation Requirements

Who Will Benefit:

  • This webinar is aimed at introducing Regulatory Affairs to individuals and industry.
Webinar Events
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Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

Speaker: Eliana Silva de Moraes, President, Brazilian Regulatory Affairs

Eliana Silva de Moraes is a Lawyer, specializing in Public Health Law (1992), graduated in Public Health Law, by Public Health School - University of Sao Paulo (1995); master degree (II) in Biomedical Law University of Coimbra, Portugal (2005), Ph.D. in European Regulatory on Public Health Law by Paris VIII University. 26 years’ experience in Pharmaceutical law, Food law, Cosmetic law, Medical Device and Equipment law, Pharmaceutical and Veterinary product for Brazil and Latin America countries, for administrative, litigation and facilitator process.

Played an active role in setting up Brazil’s Public Health Regulator (ANVISA), organizing the agenda of its first President in USA in order to explore the US System established through the Food and Drug Administration (FDA) in December 1998 as well as in the global harmonization process.

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