Course Code: KPE-C-034
Course Title: KPE’s Certificate Program in Drug Registration in African Countries
Duration: 1 Month
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.
- 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).
- 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.
- You can upgrade to KPE-C-103 KPE’s Executive Program in Drug Regulatory Affairs by paying the difference of the course fees.
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 8Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 9Importance of effective dossier management
Lecture 10Certificate of Analysis
Lecture 11Discussion on 85 common deficiency in CTD submission dossier
Lecture 12Key Consideration for Drug Master File Preparation and Submission
Lecture 13Practical Understanding on Drug Master File Preparation and Submission
Lecture 14Associated Learning: Site Master File - Detailed Understanding
Section 3Drug Registration in Specific African Countries
Lecture 15Drug Regulation and Registration in Nigeria
Lecture 16Drug Regulation and Registration in Algeria
Lecture 17Drug Regulation and Registration in Ethiopia
Lecture 18Drug Regulation and Registration in Kenya
Lecture 19Drug Regulation and Registration in Egypt
Lecture 20Drug Regulation and Registration in Ghana
Lecture 21Drug Regulation and Registration in Botswana
Lecture 22Drug Regulation and Registration in South Africa
Lecture 23Drug Registration and Regulation in Zambia
Lecture 24Drug Registration and Regulation in Sudan
Lecture 25Drug Registration and Regulation in Namibia
Lecture 26Drug Registration and Regulation in Tanzania
Lecture 27Drug Registration and Regulation in Senegal
Lecture 28Drug Registration and Regulation in Zimbabwe
Lecture 29Drug Registration and Regulation in Uganda
Lecture 30Drug Registration and Regulation in Morocco
Section 4Submission Dossier Preparation
Lecture 31Introduction to Common Technical Document (CTD)
Lecture 32Chemistry, Manufacturing & Controls
Lecture 33CMC Dossier & Compliance Management
Lecture 34Advance Practical Training on Dossier Preparation focusing on drug registration in export countries
Lecture 35Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 36Key Consideration for Drug Master File Preparation and Submission
Lecture 37Practical Understanding on Drug Master File Preparation and Submission
Lecture 38Site Master File - Detailed Understanding
Lecture 39DMF Completeness Assessment
Lecture 40Importance of effective dossier management
Lecture 41Discussion on 85 common deficiencies in CTD submission dossier
Lecture 42Data Integrity issues in Pharmaceutical Industry : Detailed Understanding
Lecture 43Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter
Lecture 44Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity
Section 5Final Certification Examination