Pharmaceutical Regulatory Affairs in Africa including South Africa
Course
In The Rembrandt Hotel, London
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School of Law - Birkbeck University of London
Master London / Classroom-basedPrice on request -
South Thames College
Vocational qualification London / Classroom-based£ 672 + VAT -
DLP India Edutech Private Limited
Master Online£ 617 VAT inc. -
Training World
Course Distance LearningPrice on request -
SCRIPT - Edinburgh University School of Law
Postgraduate Distance LearningPrice on request -
FORUM Institut für Management
Course OnlinePrice on request -
Online Learning College
NVQ Online£ 355
Description
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Type
Practical seminar
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Level
Intermediate
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Location
The rembrandt hotel, london
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Class hours
8h
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Duration
2 Days
Pharmaceutical Regulatory Affairs in Africa, including South Africa. Countries to be covered include Botswana, Ethiopia, Ghana, Kenya, Maghreb, Malawi, Mozambique, Nigeria, Namibia, South Africa, Tanzania, Uganda, Zambia, Zimbabwe and French Speaking Africa. 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.
Facilities
Location
Start date
Start date
About this course
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
Harmonisation and Co-operation Initiatives in Africa
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 regions. It will be useful as both an introductory or a refresher course on recent developments.
Reviews
Subjects
- Africa
- French Speaking
- Pharmaceutical Regulations
- Medical
- Medical training
- Medical Science
- Regulations
- Guidelines
- Management
- Pharma
Teachers and trainers (1)
Salma Ismail
CEO of Twinz, Regulatory Affairs Pharmacist Consultant, South Africa
Course programme
Key regions to be covered include:
Botswana, Ethiopia, Ghana, Kenya, Maghreb, Malawi, Mozambique, Nigeria, Namibia, South Africa, Tanzania, Uganda, Zambia, Zimbabwe and French Speaking Africa
Introductions & Welcome
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
- Complimentary & alternative medicines status
- Medical Devices
- Marketing code for the advertising of medicines
General Discussion
- Harmonisation and co-operation initiatives in Africa
Additional information
Pharmaceutical Regulatory Affairs in Africa including South Africa
-
School of Law - Birkbeck University of London
Master London / Classroom-basedPrice on request -
South Thames College
Vocational qualification London / Classroom-based£ 672 + VAT -
DLP India Edutech Private Limited
Master Online£ 617 VAT inc. -
Training World
Course Distance LearningPrice on request -
SCRIPT - Edinburgh University School of Law
Postgraduate Distance LearningPrice on request -
FORUM Institut für Management
Course OnlinePrice on request -
Online Learning College
NVQ Online£ 355