This is a recording of a webinar presented in November 2019.
Overview
This webinar will analyse applicable legislation and discuss the key issues for medical device products marketed in South America under the new EU-Mercosur agreement. Understand the similarities and challenges between both systems to develop regulatory strategies.
Learning objectives
The webinar will cover:
- What are the recent changes in South America regulatory affairs regarding the ambitious free-trade agreement between Mercosur and EU
- How to develop your medical device RA strategy under the free-trade agreement between EU and Mercosur
-
Understand the significant impact of marketing medical device products in the region
- How medical device companies will deal with the cutting-edge issues
Target Audience
Regulatory professionals from beginners to experts in the medical device sector who are interested in the business between EU and Mercosur countries.
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 harmonisation 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 1.5 CPD hours for successful completion. To learn about why CPD is important visit the Lifelong Learning page.
How do I register?
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.