TypeOnline Course
Price$390 / Rs. 19500
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drug registration in latin american countries

Introduction

Features

Duration

Admission

Course Code: KPE-C-069

Course Title: KPE’s Certificate Program in in Drug Registration in Latin American (Latam) Countries

Course Objective: The objective of this course is to impart knowledge and understanding of Drug Registration Procedure in Latam countries, Regulations, Registration procedure, country specific Common Technical Documents, LATAM 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 LATAM countries. 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 LATAM countries.

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

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Course Flow / Syllabus

Section 1Basic Orientation: Latin America Region
Lecture 1Download Study Modules
Lecture 2Different Business Regions in Pharmaceutical Business
Lecture 3Detailed understanding on Latam Pharma Market
Section 2Drug Discovery and Development
Lecture 4Overall understanding
Lecture 5Investigational New Drug
Lecture 6New Drug Application
Lecture 7Basic concept and understanding of the Generic Drug
Lecture 8Abbreviated New Drug Application (ANDA) 
Section 3Country Profiles and Drug Regulation & Registration in Latin American Countries
Lecture 9Argentina Pharmaceutical Market and Drug Registration Process
Lecture 10Bolivia Pharmaceutical Market and Drug Registration Process
Lecture 11Brazil Pharmaceutical Market and Drug Registration Process
Lecture 12Chile Pharmaceutical Market and Drug Registration Process
Lecture 13Colombia Pharmaceutical Market and Drug Registration Process
Lecture 14Mexico Pharmaceutical Market and Drug Registration Process
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