Management Forum Logo

Presented by
Management Forum

Pharmaceutical Regulatory Affairs in Africa Training Course

Covering the key regions of South Africa, Namibia, Zimbabwe, Zambia, Malawi, Tanzania, Kenya, Uganda, Nigeria, Ghana and Maghreb countries - Algeria, Morocco, Tunisia

17-18 June 2024
+ 19-22 November 2024 »
from £1099

Need help? Enrol or reserve

Format: Live online
CPD: 12 hours for your records
Certificate of completion

Download Print Enrol or reserve

Course Overview

The value of the African pharmaceutical market is increasing and growth is expected to continue at a rapid pace. There are a number of distinct markets within the region, each with their own economic and regulatory characteristics. This event will explore the key areas of African regulatory affairs, including the new SAHPRA guidelines in South Africa, and will focus on practical aspects to assist with your regulatory activities. The expert speakers will share their knowledge of working in the region and the programme will include interactive discussion sessions to enable you to share experiences with other delegates.

Covering the key regions of Algeria, Botswana, Ethiopia, Ghana, Kenya, Malawi, Morocco, Mozambique, Namibia, Nigeria, South Africa, Tanzania, Tunisia, Uganda, Zambia, Zimbabwe.

Benefits of attending:

Gain an overview of the regulatory requirements within African countries
Understand requirements for company and product registration
Learn practical information on compiling dossiers
Discuss the new SAHPRA guidelines in South Africa
Explore the harmonisation and cooperation initiatives in Africa, including the new African Medicines Agency

Participants will receive a course material folder containing comprehensive documentation provided by the speakers, which will be a valuable source of reference for the future.

This course is part of our Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.

Who should attend?

This event will be of particular interest to all those who need to learn about successful marketing authorisation applications and regulatory compliance in key African areas. It will be useful as both an introductory and a refresher course on recent developments.

Enrol or reserve

The Pharmaceutical Regulatory Affairs in Africa course will cover:

Basic terms & environment

Harmonisation initiatives within Africa

Regional presentations

Each regional presentation will cover:

The development of drug control
- The regulatory authorities
- Other influences
Regulatory submission strategy
- How to determine an appropriate submission strategy
- A practical approach
The development of drug control
- The regulatory authorities
- Other influences
Company and product registration
- Regulations and guidelines
- New products and line extensions
- Labelling requirements
- Registration samples and certification/legalisation
Compilation of the dossiers
- Contents and formats
- Hints on success/failure
- Specific country requirements
Regulatory authority/agency assessment
- Process
- Timelines

South Africa

Influences and changes
The new SAHPRA guidelines
Latest regulatory processes adopted by SAHPRA
Complementary and alternative medicines status
Marketing code for the advertising of medicines

Namibia

Botswana

Zimbabwe

Zambia

Malawi

Tanzania

Kenya

Uganda

Nigeria

Ghana

Maghreb Countries - Algeria, Morocco, Tunisia

Final discussion session

Enrol or reserve

Salma Ismail
Twinz Regulatory Affairs Pharmacist Consultants

Salma Ismail is the CEO of Twinz Regulatory Affairs Pharmacist Consultants based in South Africa. Salma has over 20 years of experience within the Pharmaceutical Industry and in Regulatory Affairs, which includes understanding of legislation, technical issues, marketing regulations and training people within the pharmaceutical industry.
Her company is very involved with the submission of product applications for registration to regulatory authorities in South Africa and English speaking Africa for products from a diverse area that includes new chemical entities, generic molecules, biological medicines, complementary medicines including health supplements, medical devices and applications to regulatory authorities within the SADC region. Her company also deals with product life cycle maintenance by dealing with variations for submission to the authorities.
She is also involved in academia by lecturing on relevant pharmaceutical regulatory matters in prestigious universities in South Africa as well as training people from within the pharmaceutical industry environment. Salma is the former Chairperson of SAPRAA (Southern African Pharmaceutical Regulatory Affairs Association).

More details

Makram Nehme

Makram Nehme is a Regional Regulatory Consultant having relevant experience with multiple multinationals including Parexel international, based in Lebanon. He has more than 10 years’ experience in the Pharmaceutical and Medical Device Industry and is a Regulatory Expert covering the Middle East and North African markets. His experience includes negotiations with the Ministry of Health and Drug Agencies in the region, as well as training of key personnel and he has a proven record in regulatory submissions, analysis, product pricing and reimbursement across the MENA region.

More details

NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

30% off the 2nd delegate*
40% off the 3rd delegate*
50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

17-18 June 2024

Live online

09:00-16:00 UK (London) (UTC+01)
10:00-17:00 Paris (UTC+02)
04:00-11:00 New York (UTC-04)
Course code 13818

GBP 1,099 1,299
EUR 1,589 1,869
USD 1,817 2,129

Until 13 May

2 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

19-22 November 2024

Live online

13:30-17:00 UK (London) (UTC+00)
14:30-18:00 Paris (UTC+01)
08:30-12:00 New York (UTC-05)
Course code 14028

GBP 1,099 1,299
EUR 1,589 1,869
USD 1,817 2,129

Until 15 Oct

4 sessions of live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.