KPE – C- 034 Drug Registration in African countries

Course Objective

The objective of this Drug Regulatory Affairs in African is to impart knowledge and understanding of Drug Registration Procedure in various African countries. The course trains the candidate on Regulations, Registration procedure, Country specific Common Technical Document Guidelines and Dossier Preparation. Moreover, this online course includes hands on training on country specific dossier preparation.

This online African Drug Regulatory Affairs online training course utilizes interactive learning tools to guide each participant through the steps of the marketing authorization strategic planning for carrying out pharmaceutical registration in 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.

Benefit of the Course:

• Orientation to practical understanding in the entire African countries drug regulation, registration procedure, country specific common Technical Documents guidelines and drug dossier preparations.
• Simulation to real life Strategic planning in marketing authorization application in African countries. Hence, the course focuses on building the advance decision making skills in African Drug Regulatory Affairs.

Course Features:

• 24×7 access. Attend Live Lectures of all different chapters and study content at your own convenient time.
• Simulation based learning.
• Self assessment modules to check the competency.
• Online final examination.
• Get certified.

Course Content Flow:

This course is divided into following modules

• Overview of the African countries : Country Introduction.
• Analyzing prevailing regulatory norms prevailing in African countries
• Advance understanding on Drug Regulation and Registration Process of the each countries.
• Comparison Study of different countries regulations and approval process
• Comprehensive training on drug registration dossier preparation.
• Strategic planning for various type of the marketing authorization.
• Registration of different class of pharmaceuticals like innovative pharmaceutical, biotech Products, Generic and Biosimilar products in African countries
• Marketing authorization handling – variation and renewal.
• Drug Registration Process – Time Line (country specific).

Course deliverable

• Upon completion of the fees payment, you can login and start accessing the course.
• You can download the African DRA PDF module (book – 282 pages) at the beginning.
• You can further start accessing all lectures one by one.
• At the end of the course, you can attempt online final examination to complete the course and get certified.

Course Upgrade

• You can upgrade to KPE-C-103 KPE’s Executive Program in Drug Regulatory Affairs by paying the difference of the course fees.