The recent changes in the Brazilian regulatory system - What are the predict for pharmaceutical, medical, cosmetic and food control in the new government?
Instructor:
Eliana Silva de Moraes
Product ID: 705675
- Duration: 3 hrs
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
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.
Refund Policy
Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
