Pharmaceutical Regulatory Affairs in Africa

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

12-13 Oct 2020

GBP 1,499
EUR 2,099
USD 2,338

Book now

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.

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.

Programme

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

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

Recent developments in 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

Harmonisation initiatives within Africa

  • African Medicines Regulatory Harmonisation (AMRH)
  • The new African Medicines Agency (AMA)

Final discussion session

Book now

12-13 Oct 2020
12-13 Oct 2020 Rembrandt Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
Enrol now

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Previous customers include...

  • Abbott Laboratories Limited
  • Adamed Sp. z o.o.
  • Allergan UK Limited
  • Almac Group
  • Biogen Idec Ltd
  • Cheplapharm Arzneimittel GmbH
  • Chugai Pharma Europe Ltd
  • CSL Behring AG
  • Dafra Pharma International
  • Demo SA Pharmaceutical Industry
  • Engelhard Arzneimittel GmbH KG
  • F. Hoffmann-La Roche Ltd
  • Fresenius Kabi
  • Helm AG
  • Ipsen Pharma SAS
  • LEO Pharma
  • Leo Pharmaceutical Products Sarath Ltd
  • LES LABORATOIRES SERVIER
  • Menarini Ricerche S.p.A.
  • Merck Serono SA
  • Merck Sharp & Dohme
  • NOVO NORDISK
  • Parexel International GmbH
  • Ranbaxy Laboratories Limited
  • Remington Pharmaceuticals
  • Sanofi Synthelabo Recherche
  • Shire Pharmaceutical Ltd
  • Stiefel Labs (UK) Limited
  • Waymade Plc
  • Zentiva ks

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

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

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

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

Very satisfied, clear detail that are very helpful

Thomas Carter, Regulatory Project Manager, Abbott Laboratories Limited

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

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

Good speakers

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