This guideline is intended to provide requirements to applicants wishing to submit
applications for registration of medicines in Botswana.
The provision of safe and efficacious blood and blood components for transfusion or manufacturing use involves a number of processes, from the selection of blood donors and the collection, processing and testing of blood donations to the testing of patient samples, the issue of compatible blood and ...its administration to the patient. There is a risk of error in each process in this “transfusion chain” and a failure at any of these stages can have serious implications for the recipients of blood and blood products. Thus, while blood transfusion can be life-saving, there are associated risks, particularly the transmission of bloodborne infections.
Screening for transfusion-transmissible infections (TTIs) to exclude blood donations at risk of transmitting infection from donors to recipients is a critical part of the process of ensuring that transfusion is as safe as possible. Effective screening for evidence of the presence of the most common and dangerous TTIs can reduce the risk of transmission to very low levels.
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This Indicator-Based Pharmacovigilance Assessment Tool (IPAT) was developed as a comprehensive performance metric for pharmacovigilance and medicine safety systems.
This guidance aims to assist leaders in the development or revision of humanitarian-sector contributions to district-level pandemic preparedness and response planning. It is directly linked to H2P guidance for national-level planning.
This publication by UNAIDS, UNDP and the International Organisation for Migration examines various dimensions related to migration and HIV and AIDS.