TypeOnline Course
Student Enrolled1
Price$330 / Rs. 16500
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Course Title: KPE’s Certificate Program in Drug Registration in African Countries

Course Objective: The objective of this course is to impart knowledge and understanding OF Drug Registration Procedure in African countries – Regulations, Registration procedure, Country specific Common Technical Document guidelines and dossier preparation. Course includes hands on training on country specific dossier preparation.

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

2. Simulation to real life Strategic planning in Drug Registration in African countries.

3. Access to Industry Data bank

4. Access to 1000’s of Pharmaceutical Case Studies

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

Duration: 1 Month


Course Description

This online course utilizes interactive learning tools to guide each participant through the steps of drug regulation and registration process for the African countries. The course is designed to challenge students 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 pace, allowing the user to stop and start at their leisure.

This course is divided into following modules

1. Overview of the African countries : Country Introduction

2. Introduction to Drug Regulation and Registration Process of the each countries

3. Introduction to Common Technical Document

4. Comparison Study of different countries regulations and approval process

5. Analysing prevailing regulatory norms prevailing in African countries

6. Drug Dossier Preparation : Interactive Session

7. Drug Registration Process – Time Line (country specific)

8. Registration of Innovative Pharmaceutical, biotech Products, Generic and Biosimilar products in African countries

Section 1Basic Orientation: African Union (AU)
Lecture 1African Continent Overview - Brief introduction to course
Lecture 2African Pharma Market
Lecture 3Drug Registration - African medicines regulatory
Lecture 4Basic Export Requirement for African Countries
Lecture 5Export Documentations & Important Concepts
Section 2Dossier Requirements for African Countries
Lecture 6Dossier Preparation - Fundamental Understanding
Lecture 7Advance Practical Training on Dossier Preparation
Lecture 8Stability Study
Lecture 9Module on Interchangeability 
Lecture 10Stability Testing of API 
Lecture 11Stability Testing of Finished Pharmaceutical Products
Lecture 12Review Test on Stability Testing 
Lecture 13Certificate of Analysis
Lecture 14Importance of effective dossier management
Section 3Drug Registration in Specific African Countries
Lecture 15Nigeria - Drug Registration
Lecture 16Drug Registration in Algeria
Lecture 17Drug Registration in Ethiopia
Lecture 18Kenya - Drug Registration
Lecture 19Egypt - Drug Registration
Lecture 20Drug Registration in Ghana
Lecture 21Drug Registration in Botswana