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
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
Speakers
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.
