When: 8 December | 12:00 GMT
Overview
This webinar will address the most recent changes in Brazilian legislation on medical devices and provide an overview of the country's medical devices approvals process.
Learning objectives
After attending this webinar participants will:
- Have an overview on the regulatory notification and registration process
- Understand the electronic process system
- Understand risk evaluation and the minimum safety and efficacy criteria
- Understand the technovigilance process
- Learn about combined products
- Learn about trends and challenges
Target Audience
Regulatory affairs professionals with 2-5 years' experience who are interested in the current processes and updates for Brazil. Professionals who want to build on their general regulatory knowledge of medical devices regulations
Speaker
Eliana Moraes played an active regulatory role in setting up Brazil’s Public Health Regulator (ANVISA), organising 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.
She is a lawyer, specialising in Public Health Law (1992), graduated in Public Health Law, by Public Health School - University of São Paulo (1995); master degree (II) in Biomedical Law University of Coimbra, Portugal (2005), PhD in European Regulatory on Public Health Law by Paris VIII University.
Eliana has 27 years experience in Pharmaceutical law, Food law, Cosmetic law, Medical Device and Equipment law, Pharmaceutical and Veterinary product for Brazil and Latin America countries. Specialised in food and drug law between Latin America and EU.
CPD
This course offers 1 CPD hours for successful completion. To learn why CPD is important visit our Lifelong Learning page.
How do I register?
Simply log in or create an account and then register using the 'Register Myself' button that will appear below once you are logged in.
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Prices
| Type |
Member |
Non-member |
| Standard |
£70 + VAT |
£95 + VAT |
Discounted Places
A limited number of discounted places are available at the rates below for those:
Please email meetings@topra.org for a discount code before making your booking.
| Type |
Member |
Non-member |
| Discount |
£35 + VAT* |
£47.50 + VAT* |
* VAT, if applicable, is charged at a rate of 20%.
Terms and conditions
By purchasing this webinar, you are agreeing to the terms and conditions.