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
* Please note, events may be cancelled due to commercial or organisational reasons. In this case Research and Markets will refund all registration fees which have already been paid. Research and Markets will not refund any charges arising from the participant having to cancel or re-book transportation or accommodation which he or she has arranged.
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
- Labeling requirements
- Registration samples and certification/legalisation
Compilation of the dossiers
- Contents and formats
- Hints on success/failure
- Specific country requirements
Regulatory authority/agency assessment
Recent developments in South Africa
- Influences and changes
- Complementary and alternative medicines status
- Medical devices
- Marketing code for the advertising of medicines
Salma Ismail is CEO of Twinz, Regulatory Affairs Pharmacist Consultants based in South Africa.Her responsibilities are to evaluate and understand legislation so as to ensure practical implementation within the pharmaceutical industry.Salma’s experience covers many countries within the SADC region, with particular attention to NCE submission, generic submissions and Biologicals. Her expertise lies in Regulatory Affairs including Legislation, Technical issues, Marketing Regulations and Training. Salma is an executive member of SAPRAA (SOUTH African association of pharmacists in regulatory affairs) as well as and executive member of HPASA (Health products association of South Africa).She is also involved in academia by lecturing on relevant pharmaceutical regulatory matters in Universities in South Africa.
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.
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.
The Rembrandt Hotel
11 Thurloe Place
Opposite V&A Museum.
Nearest underground station: South Kensington.