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Guidance for the preparation and submission of dossiers
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
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This Technical Brief reviews current practice and evidence on nutrition-specific preventive approaches to MAM, providing practical guidance for implementers and programme managers, and highlighting gaps in evidence and guidance.
The Virtual cGMP Training Marathon for Vaccine Manufacturing: Principles into Practice took place from 12 Sep to 10 Oct 2023 to continue to provide manufacturers & regulators with a comprehensive array of topics to build understanding of current WHO & international
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Session V: Regulatory & quality assurance aspects
Update on prequalification of ARVs and regional harmonisation of medicine registration
Deusdedit K. Mubangizi
Group Lead, Inspections, WHO-PQT E-mail: mubangizid@who.int
Acknowledgements:
• Matthias Stahl
• Milan Smid
• Antony Fake
...
A global Review of evidence and practice
PQM conducted an assessment of the medicine quality assurance and quality control systems in Rwanda during November 9-13, 2009. Medicine quality assurance remains to be developed in Rwanda: the country has neither a medicine regulatory authority (MRA) nor a national medicine quality control laborato
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Сборник индикаторов для мониторинга и оценки национальных программ борьбы с туберкулезом
recommended
Борьба с туберкулезом представляет собой одну из ведущих областей, в которых ведется регулярный сбор информации, которая измеряет самые критические показатели вы
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Report of a WHO technical consultation meeting
Ouagadougou, Burkina Faso
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
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The document contains a set of indicators that can be used for monitoring traditional and complementary medicine (T&CM) systems in a country.
The core indicator set consists of 16 indicators that were considered essential and collectively able to provide information on T&CM inputs, processes and ou
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