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Pharmaceutical Regulatory Affairs in Africa Training Course

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

& 25-26 May 2022 , 23-24 Nov 2022

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Details

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.

Programme

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

Presenter

Salma Ismail (More...)

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).

Book now

Book now

24-25 Nov 2021
Live webinar
24-25 Nov 2021
Live webinar
GBP 1,299 1,099
EUR 1,859 1,579
USD 2,098 1,786
Until 20 Oct*
Online registration unavailable: this date is nearing full capacity; please contact us to register.
25-26 May 2022
Live webinar
25-26 May 2022
Live webinar
GBP 1,299 1,099
EUR 1,859 1,579
USD 2,098 1,786
Until 20 Apr 22*
Enrol now
to attend
Live webinar
23-24 Nov 2022
Live webinar
23-24 Nov 2022
Live webinar
GBP 1,299 1,099
EUR 1,859 1,579
USD 2,098 1,786
Until 19 Oct 22*
Enrol now
to attend
Live webinar

Learn more about our face-to-face and webinar training formats.

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

Continuing professional development

This course qualifies for 12 hours for your CPD records.
More about CPD

Customised in-house training

We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.

Contact us

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Previous customers include...

  • Abbott Laboratories Limited
  • AbbVie
  • Acino Pharma AG
  • Amgen Ltd
  • Bayer Pharma AG
  • Biogen Idec Ltd
  • BioMarin Pharmaceutical Inc
  • Cambridge Healthcare Supplies Ltd
  • Dafra Pharma International
  • Eisai Ltd
  • F. Hoffmann-La Roche Ltd
  • FAES Pharma SA
  • Groupe Servier
  • Hexal AG
  • Janssen Infectious Diseases - Diagnostics BVBA
  • Janssen Research and Development
  • KEMRI Wellcome Trust Research Programme
  • Laboratorios Cinfa, S.A.
  • Leo Pharmaceutical Products Sarath Ltd
  • Medicines for Malaria Venture
  • Menarini Ricerche
  • Merck Sante s.a.s.
  • Merck Sharp & Dohme
  • Remington Pharmaceuticals
  • Sanofi Pasteur SA
  • Sanofi Synthelabo Recherche
  • Sanofi-Aventis South Africa
  • Shire Pharmaceutical Ltd
  • Subiaco Associates Ltd
  • Zentiva ks

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!

Angela Turner, Associate Director GRA, May 21

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., Nov 20

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 18

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 18

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 17

Very satisfied, clear detail that are very helpful

Thomas Carter, Regulatory Project Manager, Abbott Laboratories Limited, Oct 17

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 17

Good speakers

Marta Abascal, International Market Access, Laboratorios Cinfa, S.A., Oct 16

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 16

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 16