3 Hrs. Virtual Seminar: The recent changes in the Brazilian regulatory system - What are the predict for pharmaceutical, medical, cosmetic and food control in the new government?

Eliana Silva de Moraes

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Learn marketing authorization process for health products in Brazil with focus on documentation, approval process, labeling, advertising, post marketing vigilance. Understand the health protection goals of the law; Polices to meet the applicable regulations. Learn how to harmonize your regulatory strategy for getting approval at less time and cost. How the agency ANVISA works.

Why Should You Attend:

The purpose of this comprehensive web seminar is to describe the system of Brazilian regulatory affairs (for pharmaceuticals, food, and medical, cosmetic, veterinary and house hold products) and help the participants acquiring RA knowledge and understand how to obtain their product approval as per Anvisa legislation. (Brazil’s Public Health Regulator)

Learn from the expert who played an active role in setting up Brazil’s Public Health Regulator (ANVISA), how to prepare your application form and submit them to Anvisa for your product approval. How to save time and cost by planning an efficient Regulatory Affairs plan. Boost your current knowledge of the Brazilian Regulatory Affairs and gain better results in your day-by-day dealing with Anvisa. The course will also support on wider issues covering the cases/example submitted to Anvisa.

Areas Covered in the Webinar:

  • Brief History of the Brazilian Health Statutory Bases
  • Overview of challenges and opportunities in the development of business in Brazil
  • Important steps to consider while starting your business in Brazil
  • The Brazilian Agency – Anvisa: How it is organized and Works
    • Multiple departments of relevant regulatory issues
  • Regulation of Pharmaceutical, Medical Device, Food, Cosmetic, Vet and House Hold Product
  • General Overview
  • Types of Products
    • Product Approval in Brazil – Anvisa
  • Registration submission, renewals and variations of the marketing authorization.
  • How to Launch a pharmaceutical, food, cosmetic, medical device, vet and house hold products in Brazil
    • Administrative Procedures – Product Approval in Anvisa
      • Statutory requirements for the companies
      • Documents
      • Timeframe
      • Fees
    • Overview of Preparation of documentation to submit to Anvisa;
    • Understand the process to obtain marketing approval in Brazil
    • Submission, renewals and variations of the marketing authorization
    • Harmonization RA process
    • Regulatory Affairs strategies - importation, distribution, advertising, labeling, commercialization, GMP and post-market vigilance
  • Understand the health protection goals of the law; Polices to meet the applicable regulations
  • Opportunity to learn about theoretical cases with exercises & examples

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
Webinar Events
Live -Coming soon!

Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

Speaker: 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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