DUBLIN--(BUSINESS WIRE)--The "Pharmaceutical Regulatory Affairs in Africa" conference has been added to ResearchAndMarkets.com's offering.
Pharmaceutical Regulatory Affairs in Africa, including South Africa, Algeria, Botswana, Ethiopia, Ghana, Kenya, Malawi, Morocco, Mozambique, Nigeria, Namibia, South Africa, Tanzania,Tunisia, Uganda, Zambia and Zimbabwe.
The aim of this seminar is to provide you with an understanding of the key areas of regulatory affairs in the region, a focus on the practical aspects to assist with regulatory activities. Also, the opportunity for you to participate in interactive discussions and exchange experiences with other delegates.
Topics to be covered at this meeting
- Overview of the Regulatory Requirements within African countries
- Company and product registration
- Practical information on Compiling Dossiers
- How to comply with Regulatory Submission Strategy
- Recent developments in South Africa
Who Should Attend:
This seminar will be of particular interest to all those who need to learn about successful marketing authorisation applications and regulatory compliance in English speaking Africa. It will be useful as both an introductory or a refresher course on recent developments.
Agenda:
Introduction and welcome - General terms/dictionary
- Harmonisation initiatives within Africa
The development of drug control
- The regulatory authorities
- Other influences
Regulatory submission strategy
- How to determine an appropriate submission strategy
- A practical approach
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
- Complementary and alternative medicines status
- Medical devices
- Marketing code for the advertising of medicines
For more information about this conference visit https://www.researchandmarkets.com/research/wcxnxp/pharmaceutical?w=4
