Presented by
Management Forum

Pharmaceutical Regulatory Affairs in Africa

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

24-25 Nov 2021 + 2 more dates

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

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.

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.

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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

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Salma Ismail

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

Book Pharmaceutical Regulatory Affairs in Africa Live online training

24-25 Nov 2021

Live online

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 11917

  • GBP 1,299
  • EUR 1,859
  • USD 2,098
Online registration unavailable: this date is nearing full capacity; please contact us to register.

25-26 May 2022

Live online

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 11641

  • GBP 1,099 1,299
  • EUR 1,579 1,859
  • USD 1,786 2,098

Until 20 Apr

View basket 

23-24 Nov 2022

Live online

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 11918

  • GBP 1,099 1,299
  • EUR 1,579 1,859
  • USD 1,786 2,098

Until 19 Oct

View basket 

Reviews of IPI's Pharmaceutical Regulatory Affairs in Africa training course


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

Angela Turner
Associate Director GRA,

Nov 11 2020

Very good, especially the opportunity to ask specific questions to the speaker with so much experience on the field.

Laia Gispert
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.

Joanne Breare
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.

Mark Pellett
Associate Director, Biogen Idec Ltd

Oct 2 2017

Very satisfied, clear detail that are very helpful

Thomas Carter
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.

Julia Bradley
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.

Olivia Blanchet
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.

Nicoleta Vizi
Jr. Manager Global Regulatory Affairs, B. Braun Pharmaceuticals

Oct 4 2016

Good speakers

Marta Abascal
International Market Access, Laboratorios Cinfa, S.A.

UK

  • Abbott Laboratories Limited
  • Abbott Laboratories Ltd
  • Abbvie Ltd
  • Allergan UK Limited
  • Almac Group
  • Amdipharm Mercury Company Limited
  • Amgen Ltd
  • AstraZeneca UK Ltd
  • Besins Healthcare
  • Biogen Idec Ltd
  • Boehringer Ingelheim Ltd
  • Britannia Pharmaceuticals Ltd
  • Business Monitor International Ltd
  • Cambridge Healthcare Supplies Ltd
  • Celgene Europe Ltd
  • Chugai Pharma Europe Ltd
  • Colorcon Ltd
  • Eisai Ltd
  • Gilead Sciences
  • Gilead Sciences International
  • Gilead Sciences International Limited
  • GlaxoSmithKline
  • Informa Healthcare Limited
  • Janssen Research and Development
  • Janssen-Cilag Ltd
  • Martindale Pharma
  • Medicines and Healthcare Products Regulatory Agency (MHRA)
  • Novo Nordisk A/S
  • Oluwakemi Bankole
  • Reckitt Benckiser Healthcare (UK) Ltd
  • Shire Pharmaceutical Ltd
  • Stiefel Labs (UK) Limited
  • Subiaco Associates Ltd
  • Teva UK Ltd
  • Waymade Plc
  • Xidea Solutions

Germany

  • ABBOTT GmbH & Co KG
  • Abbott Laboratories GmbH
  • Bayer Pharma AG
  • Boehringer Ingelheim Vetmedica GmbH
  • CHEPLAPHARM Arzneimittel GmbH
  • Cheplapharm Arzneimittel GmbH
  • Engelhard Arzneimittel GmbH KG
  • Grunenthal GmbH
  • Helm AG
  • Hexal AG
  • Intendis GmbH
  • Merck KGaA
  • Parexel International GmbH

France

  • Abbott
  • Fresenius Kabi
  • Groupe Servier
  • Guerbet
  • Horus Pharma
  • Ipsen Pharma SAS
  • LES LABORATOIRES SERVIER
  • Merck Sante s.a.s.
  • Pierre Fabre Medicament
  • Sanofi Pasteur SA
  • Sanofi Synthelabo Recherche
  • Sanofi-Aventis Recherche & Development

Switzerland

  • AbbVie
  • Acino Pharma AG
  • CSL Behring AG
  • F. Hoffmann-La Roche Ltd
  • Medicines for Malaria Venture
  • Merck Serono SA
  • Novartis Consumer Health SA
  • Swiss Tropical Institute
  • Vifor SA

Denmark

  • Ferring Pharmaceuticals A/S
  • LEO Pharma
  • Leo Pharma A/S
  • Novo Nordisk A/S
  • Statens Serum Institut

Spain

  • Faes Farma
  • FAES FARMA, S.A.
  • FAES Pharma SA
  • GALENICUM HEALTH, S.L.
  • Laboratorios Cinfa, S.A.

United States of America

  • Abbott Laboratories
  • BioMarin Pharmaceutical Inc
  • International Partnership for Microbicides
  • Mr W Pagsuyuin
  • United States Department of Commerce

Belgium

  • Dafra Pharma International
  • Janssen Infectious Diseases - Diagnostics BVBA
  • Janssen Pharmaceutica NV
  • UCB Pharma SA

Greece

  • Demo SA Pharmaceutical Industry
  • LEO Pharma A/S
  • Leo Pharmaceutical Products Sarath Ltd
  • NOVO NORDISK AS

South Africa

  • NOVO NORDISK
  • Sanofi-Aventis South Africa
  • Schering-Plough (Pty) Ltd

United Arab Emirates

  • Astrazeneca Gulf
  • Hospira (ME & NA)
  • LEO Pharma

Italy

  • Menarini Ricerche
  • Menarini Ricerche S.p.A.

Netherlands

  • Astellas Pharma International BV
  • Merck Sharp & Dohme

Poland

  • Adamed Sp. z o.o.
  • Valeant Sp. z o.o. sp.j

Austria

  • Baxter Innovations GmbH

Cyprus

  • Delorbis Pharmaceuticals Ltd

Czech Republic

  • Zentiva ks

Iceland

  • Actavis Group PTC

India

  • Ranbaxy Laboratories Limited

Ireland

  • Labopharm Europe Ltd

Israel

  • Teva Pharmaceutical Industries Ltd

Kenya

  • KEMRI Wellcome Trust Research Programme

Norway

  • GE Healthcare AS

Pakistan

  • Remington Pharmaceuticals

Romania

  • B. Braun Pharmaceuticals

Thailand

  • Concept Foundation

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Multiple colleagues?
Talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra BEER
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy