Medical Device Registration - Brazil and Argentina

Why Should You Attend:

When considering expanding or relocating to the Brazil and Argentina, companies typically focus on business decisions and often neglect to the design a specific regulatory strategy, even though regulatory issues are an important in an effective business plan. For this reason, the first thing a company that intends to launch a product in the region has to realize is the regulatory affairs landscape.

Learn from the expert who played an active role in setting up Brazil’s Public Health Regulator (ANVISA), about the recent news/update about medical device registration system in Brazil and Argentina. You will get a comprehensive insight in the regulatory policy and implication for medical device approval in Brazil and Argentina. An opportunity to analyze and discuss key issues in medical device law. Many theoretic cases with exercises examples will be presented in this webinar.

Areas Covered in the Webinar:

• Overview of challenges and opportunities in the development of business in Brazil and Argentina
• How to develop a very good and effective regulatory affairs strategy to have success in the region
• Medical Device Approval in Brazil and Argentina
• Launching a medical device in Brazil and Argentina
• Submission, renewals and variations of the marketing authorization
• Understanding how to save time and money with your RA strategy in the region
• Harmonization RA process
• Regulatory Affairs strategies
• Polices to meet the applicable regulations
• Comprehensive overview of the necessary steps of Regulatory Affairs procedures in Brazil and Argentina
• Advertisement, Techno vigilance; Documentation Requirements
• Mergers & acquisitions, large and smaller transactions
• The important legal issues to pay attention in order to get your product approval
• Legal department; multiple departments of relevant regulatory issues
• Registration submission, renewals and variations of the marketing authorization
• Best practices of preparation of documents and submission of application to the Agencies

Who Will Benefit:

• Head of Regulatory Department
• Individuals
• Supply chain
• Heads of Purchase Department
• Projects Head
• Project Manager
• Head of Regulatory Department
• Regulatory Consultant
• Head of Quality Control
• Technical Responsible
• Head of Legal Dept
• Project Marketing
• Head of IT Department

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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