The Brazilian Pharmacovigilance System

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.

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One User Unlimited access to all recorded webinars for 6 Months

Recorded Version Only

(PPT + Recorded Streaming Link)

1x Person - Unlimited viewing for 6 Months (For multiple locations contact Customer Care)
rec Recorded Link and Ref. material will be available in My Account Section
Last Recorded Date: Dec-2019

CD or USB Drive Only

(PPT + Recorded Training File)

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(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days
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Fax: +1-650-362-2367


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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:
  • Regulatory affairs
  • Pharmacovigilance professional
  • Compliance
  • Public health advocates
  • Researchers
  • Manufacturers
  • Lawyers
  • Consumer interest groups
  • Entrepreneurs and governmental agencies.
Instructor Profile:
Eliana Silva de Moraes 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.

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email call +1-888-771-6965 (Toll Free).

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