The Brazilian Pharmacovigilance System
Instructor:
Eliana Silva de Moraes
Product ID: 706204
Training Level: Basic to Advanced
- Duration: 90 Min
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.
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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Refund Policy
Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
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. ComplianceOnline 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. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar 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 [email protected] call +1-888-717-2436 (Toll Free).
