This course provides a summary of the current filing requirements of National Medicines Regulatory Authorities (NMRAs) in Africa, and various initiatives that have been established to improve their performance. All countries in Africa (except Sahrawi Republic), have NMRAs but their organizational set-up and functionality is variable. Some are located within Ministries of Health and others are semi-autonomous. There is progressive improvement in regulatory capacity, particularly in quality control and post-marketing surveillance, pharmacovigilance and clinical trials oversight. The potential establishment of the African Medicines Agency (AMA) in 2018 is an opportunity to improve NMRAs’ capacity in Africa.

Marketing authorisation (MA) for the applicant to be granted MA affects availability of the product on the market. A thorough knowledge on the registration requirements can avoid lengthy registration times. The regulatory landscape in Africa has changed remarkably over the past few years. Apart from the Sahrawi Republic, every country in Africa currently has a NMRA; although, the functionalities are variable across countries and they are at different levels of growth, maturity and expertise

The objective of this programme 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. Programme includes hands on training on country specific dossier preparation. This programme utilizes interactive learning tools to guide through the steps of drug regulation and registration process for the African countries.

Programme Modules

Module 1 : Overview of the African countries and Drug Registration

Module 2 : Registration of Innovative Pharmaceutical, biotech Products, Generic and Biosimilar products in African countries

Module 3 : Drug Regulation and Registration in Specific African Countries

Module 4 :Dossier requirements for African Countries

Module 5 :South African Module 1 specification for eCTD V2.0

Module 6 :Dossier preparation in South African Common Technical Document (ZA CTD) Format, ZA eCTD and Paper Submissions

Module 7 :Industry specific case studies

Eligibility

Graduate in any discipline is eligible for our Post Graduate Diploma and Certificate Programmes. For Executive Diploma programmes and Professional Certifications, you need to have at least 1 year of work experience.

Programme Duration

Minimum duration to complete this programme is 3 months and maximum is 6 months.

Programme Mode

Registrations are currently open for regular and online both modes.

Programme Deliverables

A comprehensive study material for all the modules in hard copies ensuring the needs of the audience. The accompanying training material is appropriately aligned with the current Industry’s expectations.

• Assignments for all the programme modules for continuous evaluation and guidance.
• Interactive or online live sessions on all key areas of the programme giving all flexibility to the participants.
• Online classes for all the modules will be conducted on the weekends. Moreover, a doubt clearing session will also be scheduled before the examination.
• All the efforts are made by IGMPI faculty members to make the entire programme modules easily understandable.
• Assessment and evaluation for all the programme modules in order to enhance the levels of competencies and skills of the participants leading towards the objective of application in the job.
• At the end of each programme modules, the trainers shall obtain feedback from the participants using specially designed questionnaires.
• All learning and training delivery initiatives shall be conducted in English.

Examination & Certification

IGMPI follows a credit system based on all learning activities involved in studying for all PG Diploma, Executive Diploma and Certificate Programmes. Each of your modules is equal to 4 credits. To successfully complete the programme, you will have to earn all the credits assigned to your programme.

All the participants are expected to appear for online exam and are also obliged to submit assignments after each module. After successful completion the participants will be awarded Certificate in Drug Registration (African countries) by IGMPI. For all the above mentioned modules elaborate programme material, assignment and case studies would be provided by the Institute from time to time. Details get updated on the webpage as well.

Placement Assistance & Corporate Relations

The Institute has partnered with many organizations for providing with placement assistance to in its participants. Besides, it has a robust placement cell comprised of senior level Human Resources professionals and Talent Acquisition experts which maintains close links with business and industry. This cell is continuously engaged in promoting the employability of our participants and encouraging the concerned Human Resources department and Hiring Managers to recruit/hire our participants for their vacant positions. The efforts of our placement cell also include helping with professional resume writing & interview skills.

In recent months the Institute has witnessed more and more participation from professionals working with global pharmaceutical, healthcare like Dr. Reddy's Laboratories, Aurobindo Pharma, Glenmark Generics, Cipla, Wockhardt, Pfizer, Abbott, Medtronic, Foster Corporation, IPCA Laboratories, Calyx, Bliss GVS Pharma, SeQuent, Mankind, Beryl Drugs, Allergy Therapeutics, Ciron, Sun Pharmaceutical, Novartis, GlaxoSmithKline, Ranbaxy , Biocon etc. The IGMPI's Corporate Resource Division actively recommends our students and training participants for various job requirements and specialized roles to Human Resource, Talent Acquisition as well as the heads of various departments in Pharmaceutical, Healthcare industries on regular basis.

Future career prospects

The objective of these programmes is to impart knowledge and practical understanding about the drug registration procedures that are available and the structure of the registration dossier. Professionals who are willing to have a successful career in regulatory affairs, registration and documentation for European Countries, GCC Countries, India, US market should attend this programme. These programmes are highly recommended for those who are aspiring to move into regulatory affairs from other areas within a pharmaceutical company.

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Programme Fee Details

For further enquiries, write to or call us on:
info@igmpi.ac.in / 18001031071 (Toll Free),  Phone: +91 11 26512850

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