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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
...
The pre-clinical pipeline shows more innovation and diversity, with 252 agents being developed to treat WHO priority pathogens.
However, these products are in the very early stages of development and still need to be proven effective and safe. The optimistic scenario, the report indicates, is for
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Of the 50 antibiotics in the pipeline, 32 target WHO priority pathogens but the majority have only limited benefits when compared to existing antibiotics. Two of these are active against the multi-drug resistant Gram-negative bacteria, which are spreading rapidly and require urgent solutions.
Gr
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Oxford Policy Management (OPM) - APW with UNAIDS (thru TSF)
Accessed Febr. 6, 2020
Despite Pakistan's progress in reducing the number of wild poliovirus type 1 (WPV1) cases to 8 in 2017 and 12 in 2018, 2019 has seen a significant rise in the number of WPV1 cases (41 cases as of July 8 2019). One of the most intractable challenges the Pakistan Polio Eradication Initiative (PEI) is
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The present report is based on a longitudinal analysis of assessments on mixed migration routes and dynamics, conducted over the course of 2018. It is based on six rapid thematic studies, conducted over the course of 2018, as well as a longitudinal analysis of changes in mixed migration routes and d
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Maldives has made significant strides in the area of infectious disease prevention and control. This is exemplified by elimination of malaria from Maldives in 2015 and successes in TB control. In addition, Maldives is a front runner in infectious disease prevention through successful water, sanitati
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MICROBIAL DRUG RESISTANCEVolume 24, Number 5, 2018ªMary Ann Liebert, Inc.DOI: 10.1089/mdr.2017.0383
Antibiotic resistance (ABR) is a worldwide publichealth concern, with serious health, economic, and so-cietal repercussions. Its emergence is attributed to the se-lective pressure exerted by antib
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This handbook follows a comprehensive approach to health system strengthening at borders in order to support IHR national focal points and other national agencies in developing and implementing evidence-based action plans for IHR capacity development at ground crossings. The approach includes the mo
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Infection Prevention and Control Programmes
January 2020
This document is to support local authorities, leaders and policy-makers in cities and other urban settlements in identifying effective approaches and implementing recommended actions that enhance the prevention, preparedness and readiness for COVID-19 in urban settings, to ensure a robust response
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a systematic review and meta-analysis Derek K Chu et al. on behalf of the COVID-19 Systematic Urgent Review Group Effort (SURGE) study authors.
Published: The Lancet June 01, 2020 DOI: https://doi.org/10.1016S0140-6736(20)31142-9
'We did a systematic review of 172 observational studies in health-
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This document aims to provide global guidance on poliomyelitis (polio) surveillance in the context of the COVID-19 pandemic. It comes as a technical complement to Polio eradication programme continuity, Immunization in the context of COVID-19 pandemic frequently asked questions, and is aligned with
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This document provides up-to-date guidance on laboratory studies as well as smallscale (semi-field) and large-scale field trials to assess the efficacy and determine field
application rates of new molluscicide products for control of schistosomiasis.
The UNAIDS 2020 global report is a call to action. It highlights the scale of the HIV epidemic and how it runs along the fault lines of inequalities.
Masangane Case Study
The Vesper Society commissioned ARHAP to do research on the integrated Masangane HIV/AIDS programme affiliated with the Moravian Church in Eastern Cape, South Africa. Completed in 2006, this study aimed to understand the role of the religious health assets of the Masangane ART
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The WHO Guidance for Conducting a Country COVID-19 Intra-Action Review (IAR) was developed to guide countries to conduct periodic review(s) of their national and subnational COVID-19 response, so countries do not miss critical opportunities for learning and improvement to better respond to the COVID
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These guidelines provide evidence-based guidance on the use of peripartum antiviral prophylaxis in HBsAg-positive pregnant women for the prevention of mother-to-child transmission of HBV.
6 July 2021. Three new nucleic acid amplification test (NAAT) classes are endorsed by WHO and included.
The latest operational handbook includes the new classes recommended by WHO. It aims at facilitating the implementation of the WHO recommendations by the Member States, technical partners, and ot
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