The aim of this seminar is to provide you with:
Benefits of attending:
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.
Covering the key regions of Algeria, Botswana, Ethiopia, Ghana, Kenya, Malawi, Morocco, Mozambique, Namibia, Nigeria, South Africa, Tanzania, Tunisia, Uganda, Zambia, ZimbabweEach regional presentation will cover
Recent developments in South Africa
Harmonisation initiatives within Africa
Final discussion session
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.