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Pharmaceutical Regulatory Affairs in Africa Training Course: face to face & live webinar

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

& 22-23 Mar 2021

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 (More...) (12-13 Oct 2020, 22-23 Mar 2021)

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).

Makram Nehme (More...) (12-13 Oct 2020)

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 (More...) (12-13 Oct 2020)

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

  attend Face to face attend Live webinar
12-13 Oct 2020, Rembrandt Hotel, London
12-13 Oct 2020 Rembrandt Hotel, London GBP 1,299.00
EUR 1,819.00
USD 2,026.00
Until 31 Aug*
Enrol now
to attend
Face to face
GBP 1,099.00
EUR 1,579.00
USD 1,786.00
Until 31 Aug*
Enrol now
to attend
Live webinar
22-23 Mar 2021, Venue not yet confirmed
22-23 Mar 2021 Venue not yet confirmed GBP 1,299.00
EUR 1,819.00
USD 2,026.00
Until 8 Feb 21*
Enrol now
to attend
Face to face
GBP 1,099.00
EUR 1,579.00
USD 1,786.00
Until 8 Feb 21*
Enrol now
to attend
Live webinar

Learn more about our different training formats.

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

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Previous customers include...

  • ABBOTT GmbH & Co KG
  • Almac Group
  • Amdipharm Mercury Company Limited
  • Amgen Ltd
  • Astellas Pharma International BV
  • AstraZeneca UK Ltd
  • Baxter Innovations GmbH
  • Bayer Pharma AG
  • Celgene Europe Ltd
  • Faes Farma
  • GALENICUM HEALTH, S.L.
  • GE Healthcare AS
  • Gilead Sciences
  • Gilead Sciences International
  • GlaxoSmithKline
  • Groupe Servier
  • Grunenthal GmbH
  • Helm AG
  • Hexal AG
  • Ipsen Pharma SAS
  • Janssen Pharmaceutica NV
  • LEO Pharma
  • Lundbeck Austria GmbH
  • Medicines and Healthcare Regulatory Agency
  • Merck Sante s.a.s.
  • Mr W Pagsuyuin
  • Pharmathen SA
  • Pierre Fabre Medicament
  • UCB Pharma SA
  • 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, Oct 18

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

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

Very satisfied, clear detail that are very helpful

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

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

Good speakers

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

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