Download Free Abridged Prequalification Assessment Book in PDF and EPUB Free Download. You can read online Abridged Prequalification Assessment and write the review.

The Operational guidance for evaluating and publicly designating regulatory authorities as WHO-listed authorities provide procedural information (processes, steps and timelines) and general considerations related to the evaluation and listing of a regulatory authority as a WHO-listed authority (WLA). The guidance also describes the process and criteria for renewal, re-evaluation and possible delisting, the role and responsibilities of the technical advisory group on WLAs (TAG-WLA) and the undertakings of WHO and eligible regulatory authorities.
This protocol is intended to provide Performance Evaluation Laboratories (PELs) and manufacturers with the WHO performance evaluation procedures for the prequalification assessment of HIV RDTs on capillary blood submitted for WHO prequalification assessment.
This protocol is intended to provide Performance Evaluation Laboratories (PELs) and manufacturers with the WHO performance evaluation procedures for the prequalification assessment of HIV RDTs on urine submitted for WHO prequalification assessment
This report presents the recommendations of a WHO Expert Committee commissioned to coordinate activities leading to the adoption of international recommendations for the production and control of vaccines and other biological substances, and the establishment of international biological reference materials. Following a brief introduction, the report summarizes a number of general issues brought to the attention of the Committee. The next part of the report, of particular relevance to manufacturers and national regulatory authorities, outlines the discussions held on the development and adoption of new and revised WHO Recommendations, Guidelines and guidance documents. Following these discussions, WHO Guidelines on the quality, safety and efficacy of respiratory syncytial virus vaccines; and an Amendment document to the WHO Recommendations to assure the quality, safety and efficacy of poliomyelitis vaccines (inactivated) were adopted on the recommendation of the Committee. Subsequent sections of the report provide information on the current status, proposed development and establishment of international reference materials in the areas of: antibiotics; biotherapeutics other than blood products; blood products and related substances; cellular and gene therapies; in vitro diagnostics; and vaccines and related substances. A series of annexes are then presented which include an updated list of all WHO Recommendations, Guidelines and other documents on biological substances used in medicine (Annex 1).
Diabetes is an escalating global health crisis that is expected to impact 1.3 billion people by 2050. Diabetes prevalence is predicted to increase even more steeply in low- and middle-income countries (LMICs). Between 2000 and 2019, there was a 3% increase in age-standardized mortality rates from diabetes. In lower-middle-income countries, the mortality rate due to diabetes increased by 13%. Of those with diabetes, approximately 9 million people globally live with type 1 diabetes and thus require insulin. In addition, about 60 million people with type 2 diabetes need insulin to achieve optimal glycaemic control, but only about 50% of these individuals are able to access this medication.