DUBLIN--(BUSINESS WIRE)--The "Pharmaceutical Regulatory Affairs in Africa" conference has been added to ResearchAndMarkets.com's offering.
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, and French-speaking Africa
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 its own economic and regulatory characteristics.
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.
Agenda:
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:
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The development of drug control
The regulatory authorities- Other influences
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Regulatory submission strategy
- How to determine an appropriate submission strategy
- A practical approach
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The development of drug control
- The regulatory authorities
- Other influences
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Company and product registration
- Regulations and guidelines
- New products and line extensions
- Labelling requirements
- Registration samples and certification/legalisation
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Compilation of the dossiers
- Contents and formats
- Hints on success/failure
- Specific country requirements
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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
For more information about this conference visit https://www.researchandmarkets.com/r/lscs7s
