InstructorRoyed Training
TypeOnline Course
Student Enrolled1
Price$490 USD / 27500 INR.
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Africa drug regulatory affairs


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Pharmaceutical Regulatory Affairs in Africa

Pharmaceutical Regulatory Affairs in Africa trains the candidate on pharmaceutical marketing authorization and regulatory procedures in African countries. The course provide detail training on Regulations, Registration procedure, guidelines and dossier preparation specific to african countries. Moreover course focus on the regulatory affairs strategic planning for registration of pharmaceutical, biopharmaceutical in african countries.

This advance certification course in Pharmaceutical Regulatory Affairs covers drug registration, regulation and marketing authorization strategic planning for all African countries like Nigeria, Egypt, South Africa, Tanzania, Sudan etc.

In addition, this course is designed to challenge students and Professionals to apply what they have learned through the use of interactive exercises, reflection questions, and a final assessment at the end of the course.

The course can be completed at any place. So, it allows the user to stop and start at their leisure.

Course Code: RYD-067

Course Title: Advance Certification in Pharmaceutical Regulatory Affairs in Africa

Online distance learning course. Therefore, the course can be accessed online across anywhere 24×7.

1 Month

This African Drug Regulatory Affairs online course utilizes interactive learning tools to guide each participant through to understand of the regulatory process of the African pharmaceutical market. This online certification course will focus on understanding regulatory affairs strategic management skills which is required for effective functioning as regulatory personnel. Indeed, advance simulation in the course will challenge students to apply what they have learned from the course. In addition, there are advance learning tools like interactive exercises, reflection questions, expert live chat which makes the course very interesting. african drug regulatory affairs

Benefit of African Pharmaceutical Regulatory Affairs Course

  • Gain an overview of the regulatory environment in the Africa
  • Insight on the pharmaceutical markets in Africa
  • Understand the strategic pathway for marketing authorization in African countries
  • Harmonization and recent developments in the African region

Key features of the course

  • 24×7 Online Access. Therefore, access the course anytime from anywhere across globe.
  • Students can download the course materials from dashboard. Hence, it helps them to study offline even after completion of the course.
  • Access the e-lectures, case studies, self assessment modules and practical sessions through personalized web page. 
  • Moreover, final examination is online. Hence student can attend the final examination own convenient date and time. 

Graduation in any discipline. Even the final year student can join the course.

Who should attend

  • Those who want to know about the African Pharmaceutical Market, Regulation.
  • One want to enhance knowledge about the African countries latest regulatory updates.
  • Business Development, Regulatory Affairs, IPR, strategic management professionals who want to have the detailed understand strategic planning process for registration and regulation of the pharmaceuticals in African countries.

 Certificate will be provided at the end of the successful completion of the course.

  1. Attend the course 24×7 by login to your dashboard. So, you can attend lectures, simulation, self assessment tests and final certification examination.
  2. You will also eligible to receive the course study modules. You can download by login to your course page.

Insight on African Market and Regulatory overview

A career in Regulatory Affairs is very challenging. But at the same time regulatory affairs career can be highly rewarding. It opens up lot of opportunities for professionals. But the regulatory job covers a variety of disciplines. Regulatory professional involved involved in regulatory submission, compliance, clinical trials, quality assurance, drug safety, pharmacovigilance.

The pharmaceutical market in the Africa has witnessed considerable progress over the years due to favorable demographic and economic factors. African pharmaceutical market is considered as semi regulated market. Africa’s pharmaceutical industry is valued around USD 29 billion, and it is one of the major export entry gateway for pharmaceutical companies.

Above all, there is a strong support from the government  for healthcare industry. Despite of the recent progress, the pharmaceutical sector in the Africa is still in an emerging phase. African market belongs to the class of semi regulated market. But drug regulation in African countries are evolving very fast. A vast majority of pharmaceuticals consumed in the region are of imported brand. However, the governments have been trying to increase local drug manufacturing. In turn, it will reduce reliance on imported products.

Africa’s pharmaceutical markets are growing very fast. Prescription drugs are forecast to grow at a compound annual growth rate of 6.5%, generics at 10%, over-the-counter medicines at 7.1%, and medical devices at 12.1%. Increasing urbanization, healthcare capacity and supportive business environment are the drivers of the Africa pharmaceutical market. For early movers in order to pursue competitive advantage requires focus on pockets of growth like much of the opportunity lies not at country level, but in cities. It is interesting to note that 37% of African consumers are concerted in 30 cities.

Challenges for pharmaceutical companies to market in Africa

One of the major challenge for pharmaceutical companies is  supply and distribution management. Africa, being vast continent, managing the supply chain will be challenging. Secondly, understanding the regulation is key most important for making the appropriate marketing authorization strategy. But it will be really challenging as region witness lot of pharmaceutical companies and there is no regulatory harmonization. So, understanding of regulatory strategic planning is crucial for success of pharmaceutical companies.

About regulatory affairs job>> Learn here

Section 1Drug Discovery Development to Commercialization - fundamental understanding
Lecture 1Introduction to Pharmaceutical R&D | Drug Discovery Development Process
Lecture 2Investigational New Drug Application (INDA)
Lecture 3New Drug Application (NDA) 
Lecture 4Basic concept and understanding of the Generic Drug
Lecture 5Abbreviated New Drug Application (ANDA) 
Lecture 6Handling of orange book
Lecture 7Complete Response Letter | Key understanding | Management and Action Plan
Lecture 8USFDA expedited programs
Lecture 9505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 10Authorized Generics: Key Understanding
Lecture 11Exploratory IND Vs. Traditional IND
Lecture 12Orphan Drug Designation 
Lecture 13Advance Learning on 505B2 Pathway
Lecture 14Chemistry, Manufacturing & Controls 
Lecture 15Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Lecture 16Clinical Trials : Advance Understanding |
Lecture 17Clinical Trial Protocol Writing
Lecture 18Ethics in Clinical Research
Lecture 19Review on Drug Discovery and Development 
Lecture 20Fundamental of CMC | Detailed understanding of CMC section writing | Important Points regarding CMC | Drug Product and Drug Substance | Excipient, FP, Analysis and Stability Study Requirements
Section 2Africa continent and courtliness
Lecture 21Overview - African Continent
Lecture 22Insight on African Pharma Market
Lecture 23Drug Registration - African medicines regulatory
Lecture 24Basic Export Requirement for African Countries
Lecture 25Export Documentations & Important Concepts
Section 3Country specific regulation
Lecture 26Drug Registration and Regulation in Nigeria
Lecture 27Drug Registration and Regulation in Algeria
Lecture 28Drug Registration in Ethiopia
Lecture 29Drug Registration in Kenya
Lecture 30Drug Registration in Egypt
Lecture 31Drug Registration in Ghana
Lecture 32Drug Registration and Regulation in Botswana
Lecture 33Drug Registration and Regulation in South Africa
Lecture 34Drug Registration and Regulation in Zambia
Lecture 35Drug Registration and Regulation in Namibia
Lecture 36Drug Registration and Regulation in Tazania
Lecture 37Drug Registration and Regulation in Senegal
Lecture 38Drug Registration and Regulation in Zimbabwe
Lecture 39Drug Registration and Regulation in Uganda
Lecture 40Drug Registration and Regulation in Morocco
Lecture 41Drug Registration and Regulation in Sudan
Section 4Submission Dossier Preparation, filing and management
Lecture 42Introduction to Common Technical Document (CTD)
Lecture 43CMC Dossier & Compliance Management
Lecture 44Advance Practical Training on Dossier Preparation focusing on drug registration in export countries 
Lecture 45Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 46Key Consideration for Drug Master File Preparation and Submission 
Lecture 47Practical Understanding on Drug Master File Preparation and Submission
Lecture 48Site Master File - Detailed Understanding 
Lecture 49DMF Completeness Assessment
Lecture 50Importance of effective dossier management
Lecture 51Discussion on 85 common deficiencies in CTD submission dossier
Lecture 52Data Integrity issues in Pharmaceutical Industry : Detailed Understanding 
Lecture 53Plant Inspection Management
Lecture 54Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity
Lecture 55Reference: Countries Classification based on climate and stability zone
Section 5GMP requirements
Lecture 56Certification Pharmaceutical Companies / Plants 
Lecture 57Premises & Plant Layout Designing
Lecture 58Sanitation and Hygiene
Lecture 59Equipment
Lecture 60Production Modules
Lecture 61Documentation
Lecture 62Quality Control
Lecture 63Product Complaint
Lecture 64Storage Module
Section 6CPP and WHO Certification Scheme
Lecture 65Introduction to Certificate of Pharmaceutical Product | Types of CoPP | List of Countries / Regulatory Authorities who requires CoPP | CoPP as a part of generic market expansion planning 
Lecture 66WHO-GMP Certification Scheme 
Lecture 67Template of Certificate of Pharmaceutical product | Key observations and points to note while working on CoPP