DUBLIN--(BUSINESS WIRE)--The "Pharmaceutical Regulatory Affairs in Africa" conference has been added to ResearchAndMarkets.com's offering.
Covering the key regions of Algeria, Botswana, Ethiopia, Ghana, Kenya, Malawi, Morocco, Mozambique, Namibia, Nigeria, South Africa, Tanzania, Tunisia, Uganda, Zambia and Zimbabwe.
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.
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
Agenda
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
- Complementary and alternative medicines status
- Medical devices
- Marketing code for the advertising of medicines
Harmonization 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/research/xlkp2f/2day_seminar?w=4
