Drug Regulation & Registration in Brazil

Introduction

Features

Duration

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

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Introduction

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