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

23-24 Mar 2020

GBP 1,499 1,299 *
EUR 2,099 1,819 *
USD 2,338 2,026 *
* When you book before 14 Feb

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

Presenters

Salma Ismail

Salma Ismail is CEO of Twinz, Regulatory Affairs Pharmacist Consultants based in South Africa.Her responsibilities are to evaluate and understand legislation so as to ensure practical implementation within the pharmaceutical industry.Salma’s experience covers many countries within the SADC region, with particular attention to NCE submission, generic submissions and Biologicals. Her expertise lies in Regulatory Affairs including Legislation, Technical issues, Marketing Regulations and Training. Salma is an executive member of SAPRAA (SOUTH African association of pharmacists in regulatory affairs) as well as and executive member of HPASA (Health products association of South Africa).She is also involved in academia by lecturing on relevant pharmaceutical regulatory matters in Universities in South Africa.

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.

Hélène Tchakgarian

Helene is Regulatory Affairs Manager – International RA, Emerging Marketing for Gilead Sciences in Cambridge, where she is the North Africa Regional Lead and responsible for several markets in Sub-Saharan Africa Pacific for HIV, HBC, HCV and Visceral Leishmaniasis portfolios. She has worked in Regulatory Affairs in emerging markets for the past 8 years, previously working for Sanofi in both Paris and Casablanca. She gained a Doctor of Pharmacy from the University of Paris Saclay.

Book now

23-24 Mar 2020
23-24 Mar 2020 Rembrandt Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
GBP 1,299.00
EUR 1,819.00
USD 2,026.00
Until 14 Feb*
Enrol now

* Note the early booking discount cannot be combined with any other offers or promotional code

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Previous customers include...

  • Abbott Laboratories GmbH
  • Abbott Laboratories Ltd
  • Abbvie Ltd
  • Actavis Group PTC
  • Almac Group
  • Astellas Pharma International BV
  • B. Braun Pharmaceuticals
  • Biogen Idec Ltd
  • Business Monitor International Ltd
  • Colorcon Ltd
  • Ferring Pharmaceuticals A/S
  • Gilead Sciences International Ltd
  • Informa Healthcare Limited
  • Janssen Pharmaceutica NV
  • Menarini Ricerche S.p.A.
  • Merck KGaA
  • Merck Sharp & Dohme
  • Novo Nordisk A/S
  • NOVO NORDISK AS
  • Parexel International GmbH
  • Ranbaxy Laboratories Limited
  • Reckitt Benckiser Healthcare (UK) Ltd
  • Remington Pharmaceuticals
  • Sanofi Pasteur SA
  • Sanofi Synthelabo Recherche
  • Sanofi-Aventis Recherche & Development
  • Sanofi-Aventis South Africa
  • Schering-Plough (Pty) Ltd
  • Shire Pharmaceutical Ltd
  • Vifor SA

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

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

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

Good speakers

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

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