TypeOnline Course
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Course Title: KPE’s Certificate Program in in Drug Regulation and Registration in Brazil

Course Objective: The objective of this course is to impart knowledge and understanding of Drug Regulation and Registration Procedure in Brazil. This course focus on Regulations, Registration procedure, country specific Common Technical Documents, ANVISA guidelines and dossier preparation.

This online course utilizes interactive learning tools to guide each participant through the steps of drug regulation and registration process for the country of Brazil. The course is designed to challenge students and Professionals to apply what they have learned through the use of interactive exercises, reflection questions, expert live chat and a final assessment at the end of the course.

The course can be completed at any place, allowing the user to stop and start at their leisure.

1. Orientation to practical understanding in the entire drug regulation, registration procedure, country specific common Technical Documents, LATAM guidelines and drug dossier preparations.

2. Simulation to real life Strategic planning in Drug Registration in Brazil.

3. Access to Industry Data bank

4. Access to related Case Studies

5. Attend Live Lectures of all different chapters / study content.

Upon completion of the admission process, you will be provided the course access. You can attend lectures, case studies and also you can download e-books (modules) from your page. 

1 Month

Section 1Basic Orientation: Latin America Region
Lecture 1Overview of Latin America Region
Lecture 2Segmentining the Latin America Region into Subgrups
Lecture 3Understanding of Subgroups
Lecture 4North America
Lecture 5South America
Section 2Drug Discovery and Development
Lecture 6Overall understanding
Lecture 7Investigational New Drug
Lecture 8New Drug Application
Lecture 9Generic Drug Approval
Section 3Latin America Health and Pharmaceutical Market Overview
Lecture 10Key Trends
Lecture 11Regulatory Harmonization Status in Latin America
Section 4Country Understanding
Lecture 12Overview - Brazil
Lecture 13Currency Facts : Brazil
Lecture 14Challenges of Brazil Pharmaceutical Market
Section 5ANVISA
Lecture 15Drug Regulatory Body in Brazil
Lecture 16Evolution of Regulatory Process in Country of Brazil
Lecture 17Current Regulatory Environment in Brazil
Lecture 18Intellectual Property Rights (IPR) Protection
Lecture 19Compulsory Licensing Provision in IP in Brazil
Lecture 20Drug Registration Process in Brazil
Lecture 21ANVISA Registration Process – Step By Step
Lecture 22Drug Registration Time & Fees
Lecture 23Types of Product Registration
Lecture 24Drugs Classifications
Lecture 25Documentation Needed for Registration
Lecture 26Dossier Requirements
Lecture 27Registration of Company in Brazil
Lecture 28FDA - ANVISA Brazil, Confidentiality Commitment
Lecture 29Medical Device Regulation in ANVISA
Section 6Strategic Planning to access the Brazilian market
Section 7Understanding Biologics and Biosimilars in Brazil
Lecture 31Introduction
Lecture 32Definitions and classification of Biologics
Lecture 33Registration of new biological products or biological products
Lecture 34Biosimilars approved in Brazil
Lecture 35Availability of regulatory/data exclusivity for biologics in Brazil