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1
In preparing this paper, the Pharmacovigilance Group of the Pan American Health Organization’s Pan American Network for Drug Regulatory Harmonization (PANDRH) adopted the perspective of PAHO/WHO, which considers Pharmacovigilance, an essential com
...
ponent of public health programs. Its intention was to facilitate the development of pharmacovigilance systems in the Region of the Americas and improve, strengthen, and promote the adoption of good practices to improve safety for patients and the general population, based on the needs of the Region.
Document also available in Spanish and Portuguese!
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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
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health professionals, 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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The WHO laboratory biosecurity guidance follows and complements the revision of the Laboratory biosafety manual, fourth edition and provides principles and measures to prevent lapses and incidents throughout the whole value chain of handling high-consequence biological material, technology and infor
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mation. The document shares global best practice and covers the biosecurity part of the biological risk management lifecycle, starting from collection, transportation, storage and experiment, and in specific context such as every type of biomedical laboratory, research activities, repository and biobank. It also provides key considerations and best practices for institutional, national and international levels, including regulatory oversight.
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