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 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 Profiles and Drug Regulation & Registration in Latin American Countries
Lecture 12Argentina Pharmaceutical Market and Drug Registration Process
Lecture 13Bolivia Pharmaceutical Market and Drug Registration Process
Lecture 14Brazil Pharmaceutical Market and Drug Registration Process
Lecture 15Chile Pharmaceutical Market and Drug Registration Process
Lecture 16Colombia Pharmaceutical Market and Drug Registration Process
Lecture 17Costa Rica Pharmaceutical Market and Drug Registration Process
Lecture 18Ecuador Pharmaceutical Market and Drug Registration Process
Lecture 19El Salvador Pharmaceutical Market and Drug Registration Process
Lecture 20Guatemala Pharmaceutical Market and Drug Registration Process
Lecture 21Hondurus Pharmaceutical Market and Drug Registration Process
Lecture 22Mexico Pharmaceutical Market and Drug Registration Process
Lecture 23Nicaragua Pharmaceutical Market and Drug Registration Process
Lecture 24Panama Pharmaceutical Market and Drug Registration Process
Lecture 25Paraguay Pharmaceutical Market and Drug Registration Process
Lecture 26Peru Pharmaceutical Market and Drug Registration Process
Lecture 27Uruguay Pharmaceutical Market and Drug Registration Process
Lecture 28Venezuela Pharmaceutical Market and Drug Registration Process
Section 5Comparative Study with Key Submission Requirements for Drug Registration in LATAM Countries
Section 6Latam Pharma Business Expansion and regulatory strategic orientation
Section 7LATAM vs. Other Region - Drug Regulatory requirements
Lecture 31LATAM vs. GCC Drug Regulation Comparison
Lecture 32LATAM vs. ASEAN Drug Regulation Comparison
Lecture 33LATAM vs. Asia Pacific (Other than ASEAN) Drug Regulation Comparison
Lecture 34LATAM vs. CIS Drug Regulation Comparison
Section 8Dossier Preparation Training (specific to LATAM countries)
Section 9Export Strategies for Latam Countries
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