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 their own economic and regulatory characteristics. 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.
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
Certification:
- CPD: 12 hours for your records
- Certificate of completion
Agenda
Basic terms & environment
Harmonisation initiatives within Africa
Regional presentations
Each regional presentation will cover:
- The development of drug control
- The regulatory authorities
- Other influences
- Regulatory submission strategy
- How to determine an appropriate submission strategy
- A practical approach
- The development of drug control
- The regulatory authorities
- Other influences
- 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
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
Namibia
Botswana
Zimbabwe
Zambia
Malawi
Tanzania
Kenya
Uganda
Nigeria
Ghana
Maghreb Countries-Algeria, Morocco, Tunisia
Final discussion session
Speakers
Salma Ismail,
Twinz Regulatory Affairs Pharmacist ConsultantsSalma Ismail is the CEO of Twinz Regulatory Affairs Pharmacist Consultants based in South Africa. Salma has over 20 years of experience within the Pharmaceutical Industry and in Regulatory Affairs, which includes understanding of legislation, technical issues, marketing regulations and training people within the pharmaceutical industry.
Her company is very involved with the submission of product applications for registration to regulatory authorities in South Africa and English speaking Africa for products from a diverse area that includes new chemical entities, generic molecules, biological medicines, complementary medicines including health supplements, medical devices and applications to regulatory authorities within the SADC region. Her company also deals with product life cycle maintenance by dealing with variations for submission to the authorities.
She is also involved in academia by lecturing on relevant pharmaceutical regulatory matters in prestigious universities in South Africa as well as training people from within the pharmaceutical industry environment. Salma is the former Chairperson of SAPRAA (Southern African Pharmaceutical Regulatory Affairs Association).
Makram Nehme,
Parexel internationalMakram 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.
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.
