- Palabras clave > African Medicines Regulatory Harmonization (AMRH)
- Palabras clave > clinical trials registration
- Palabras clave > harmonization of medicines regulation
- Palabras clave > marketing authorization
- Palabras clave > medicines registration
- Palabras clave > National Medicines Regulatory Authority (NMRA)
- Palabras clave > pharmacovigilance - capacity building
- Palabras clave > registration of medicinal products
- Palabras clave > regulatory harmonization
- Palabras clave > regulatory institutional capacity
- Palabras clave > enregistrement des médicaments
(2013; 72 pages) [French]
This Conference is co-organised by the NEPAD Agency African Medicines Regulatory Harmonisation (AMRH) Programme and the Department of Health, Republic of South Africa; in collaboration the World Health Organization (WHO), US Food and Drugs Administration (US-FDA); and Drugs for neglected Tropical Diseases (DNDi) with financial contributions from the World Bank, United States Pharmacopoeia (USP) and AERAS.
The overall goal of the conference is to enable policy makers, regulators, industry, academia, research organizations and scientists to network and exchange information on innovative approaches for pharmaceutical sector development in Africa. Thus it is hoped that the conference will provide a forum to share scientific advances and current best practices in regulatory science disciplines amongst policy makers, regulators, industry and scientists; review current global developments in the regulatory environment and assess their impact on the commercialization of health research products as part of implementation of the Pharmaceutical Manufacturing Plan for Africa (PMPA); contribute to global knowledge on regulatory science; and provide inputs to the third African Medicines Regulators Conference (AMRC) that is being held from 4 to 6 December 2013.
The 1st Biennial Scientific Conference on Medicines Regulation in Africa is structured to promote discussion and exchange of ideas so that all participants actively take part in generating the main conference outcomes. The format of the conference will include oral presentations, poster presentations and panel discussions to maximize contributions around the key topics. We hope that the conference will create plenty of opportunities for enriching and stimulating interactions in the medicines regulation field.