Covering the key regions of South Africa, Namibia, Zimbabwe, Zambia, Malawi, Tanzania, Kenya, Uganda, Nigeria, Ghana and Maghreb countries - Algeria, Morocco, Tunisia
★★★★★ "Presentations/content and speakers were well rounded and provided valuable information for my job th... more (10)"
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:
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.
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.
Each regional presentation will cover:
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).
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.
NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:
Please contact us for pricing if you are interested in booking 5 or more delegates
7-8 March 2024
09:30-16:00 UK (London) (UTC+00)
10:30-17:00 Paris (UTC+01)
04:30-11:00 New York (UTC-05)
Course code 13541
Until 01 Feb
23-24 July 2024
09:30-16:00 UK (London) (UTC+01)
10:30-17:00 Paris (UTC+02)
04:30-11:00 New York (UTC-04)
Course code 13818
Until 18 Jun
19-22 November 2024
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
Until 15 Oct
* 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.
Presentations/content and speakers were well rounded and provided valuable information for my job that showed the experience they had to give me confidence in the information provided. The whole program, process and all was well worth the cost and time. I will recommend to others - already have!
May 26 2021
Nov 11 2020
Very good, especially the opportunity to ask specific questions to the speaker with so much experience on the field.
Regulatory affairs Expert, GALENICUM HEALTH, S.L.
Oct 1 2018
Salma Ismail was very good. She did speak with passion and I liked her way how she presented the different topics. Makram Nehme was also very good.
Hildur Sif Pálmarsdóttir
Submission Manager, LEO Pharma
Oct 1 2018
Fantastic speaker, really experienced and able to give real 'examples' of dealing with the authorities. Lovely to be able to ask questions so readily (rather than at the end of the topic/country) - this made the day much more interesting/interactive, which I much prefer.
Regulatory Affairs Coor, Colorcon Ltd
Oct 2 2017
I thoroughly enjoyed the course and would strongly recommend to anyone who is operating in this region, irrespective of whether they are a seasoned pro in this region or new to it.
Associate Director, Biogen Idec Ltd
Oct 2 2017
Very satisfied, clear detail that are very helpful
Regulatory Project Manager, Abbott Laboratories Limited
Oct 2 2017
Very useful in my day-to-day job, thanks to Selma and Makram for their time and sharing their expertise.
Associate Manager, Gilead Sciences International
Oct 4 2016
I learnt a lot from this course, I am glad that it was taught based on experience rather than just being taught the guidelines. The information about how the process actually works rather than how it should work was very helpful.
Regulatory Affairs Associate, Besins Healthcare
Oct 4 2016
It was an amazing course, the speakers were experienced and the content of the course fitted with my expectations. It was also great to share and compare experiences in the area.
Jr. Manager Global Regulatory Affairs, B. Braun Pharmaceuticals
Oct 4 2016
International Market Access, Laboratorios Cinfa, S.A.
United States of America
United Arab Emirates
We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.
Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:
Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to: