The guidelines reiterate that the general principles of ethics for biomedical research involving human participants shall also be applicable. In addition, the guidelines specify unique provisions for stem cells, because of their inherent property for unlimited proliferation, differentiation to cells... of the germ layers, oncogenic potential, unrecognised toxicities and possible involvement in pre-implantation stages of human development. The guideline therefore focuses on: 1. Monitoring mechanism and regulatory pathway for basic, clinical research and product development based on categories of research and level of manipulation. 2. Procurement of gametes, embryos and somatic cells for derivation and propagation of any stem cell lines, their banking and distribution. 3. Other important areas like international collaboration, exchange of cell/lines and education for stakeholders and advertisement.
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Procedures Manual - Medicines registration in Madagascar - 2016 version
Every day, fake medicines and medical products are sold at street corners, in open air markets or on unregulated websites in several countries in the African Region. These poor quality, unsafe medicines and pharmaceutical products promote drug resistance and lead to loss of confidence in health prof...essionals, manufacturers and distributors and in health systems. In an effort to protect people’s health, the WHO Regional Director for Africa, Dr Matshidiso Moeti, has proposed a strategy aimed at strengthening National Medicine Regulatory Authorities (NMRAs) in order to ensure that only safe, good quality and effective medical products are available.
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This Training module on malaria elimination has been developed by WHO to support health professionals in planning, managing, monitoring and evaluating malaria elimination programmes
This Training module on malaria elimination has been developed by WHO to support health professionals in planning, managing, monitoring and evaluating malaria elimination programmes.
Supporting exercises: These files are necessary for participants to complete a number of exercises listed in the man...ual. Please go to the website: http://www.who.int/malaria/publications/atoz/9789241549424/en/
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The elimination scenario planning (ESP) manual provides malaria-endemic countries with a comprehensive framework to assess different scenarios for moving towards this goal, depending on programme coverage and funding availability. It also helps countries set realistic timelines and provides essentia...l knowledge for strategic planning in the long term.
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This document builds on the Background document prepared for the September 4-5, 2014 Consultation. It includes proposed elements to consider during the development of a framework to assist decision-making at global and national level.
The aim of the document is to assist Member States and releva...nt partners in their discussions to identify the best approaches to ensure the accelerated evaluation and use of available or near-term therapies and vaccines for the treatment and prevention of EVD. The document calls for a coordinated effort by the international community to remove unnecessary obstacles towards this goal.
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This report presents the findings from the Community Based Volunteers Skill Audit Survey that was carried out in 11 districts in Zambia as part of the Millennium Development Goal Acceleration Initiative.
These guidelines have been developed to provide guidance to the Ministry of Health in managing applications for registration of human pharmaceutical products in Rwanda. It was compiled by the Technical Working Group (TWG) on Medicines Evaluation and Registration (MER) of the East African Community M...edicine Regulatory Harmonization (EAC MRH) Project. The group relied on their experiences and knowledge on medicines registration requirements of their individual Countries. World Health Organization (WHO) and the International Conference on Harmonization of Technical Requirements of Medicines for Human Use (ICH) and other available literature.
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