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

Course Overview

The aim of this seminar is to provide you with:

  • An understanding of the key areas of regulatory affairs within English-speaking Africa and the Maghreb countries
  • A focus on the practical aspects to assist with regulatory activities
  • The opportunity for you to participate in interactive discussions and exchange experiences with other delegates

Benefits of attending:

  • Gain an overview of the regulatory requirements within English- speaking Africa and the Maghreb countries
  • Understand requirements for company and product registration
  • Learn practical information on compiling dossiers
  • Discuss recent developments in South Africa
  • Explore the harmonisation and co-operation initiatives in Africa

Why you should attend?

This seminar 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

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
  • Complementary and alternative medicines status
  • Medical devices
  • 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

We do not currently have dates confirmed for this course; please contact us to be informed when it is scheduled; or to discuss running this course on an in-house basis for your staff.

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Previous customers include...

  • ABBOTT GmbH & Co KG
  • Abbott Laboratories GmbH
  • Abbott Laboratories Limited
  • Abbvie Ltd
  • Adamed Sp. z o.o.
  • Astellas Pharma International BV
  • Baxter Innovations GmbH
  • Britannia Pharmaceuticals Ltd
  • Cambridge Healthcare Supplies Ltd
  • Colorcon Ltd
  • Demo SA Pharmaceutical Industry
  • FAES Pharma SA
  • Fresenius Kabi
  • Gilead Sciences International
  • Janssen Infectious Diseases - Diagnostics BVBA
  • Janssen Pharmaceutica NV
  • Leo Pharmaceutical Products Sarath Ltd
  • Martindale Pharma
  • Medicines and Healthcare Regulatory Agency
  • Merck Sharp & Dohme
  • Mr W Pagsuyuin
  • Novartis Consumer Health SA
  • Oluwakemi Bankole
  • Ranbaxy Laboratories Limited
  • Reckitt Benckiser Healthcare (UK) Ltd
  • Schering-Plough (Pty) Ltd
  • Teva Pharmaceutical Industries Ltd
  • UCB Pharma SA
  • Xidea Solutions
  • 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

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 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

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

Good speakers

Marta Abascal, Regulatory Affairs, Laboratorios Cinfa, S.A.

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