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
...• Jacqueline Sawyer
• Iveta Streipa
D-Building – UNAIDS
Kofi A. Annan Meeting Room
Wednesday, 9 March 2016 11:15 – 11:30
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Objective: The study aimed to describe the current epidemiological, clinical and immunological profile of newly
detected HIV - positive patients in Northern Benin by 2016. Methods: It was a prospective study conducted from May 2 to
October 31, 2016 on three main sites of care of people living with... HIV (PLHIV) in the department of Borgou in Benin. All
new cases of HIV infection have been systematically and comprehensively recruited. Initial epidemiological, clinical and
immunological data were collected using a questionnaire. These data were entered and analyzed using the Epi Info 7 software.
Results: In total, 185 adults (68 male and 117 female) newly screened HIV positive were included in this study. The middle age
was 36.2 ± 10.9 years and the sex ratio was 0.6 One hundred and thirty-five patients (73%) were between 25 and 50 years old.
In terms of the profession, 132 patients (71.3%) were engaged in liberal activities (craftmen, traders and retailers). The
majority was schooled (113 or 61.1%) and resided in urban areas (146 or 79%). One hundred and sixteen patients lived in
couple (62.7%) with an average monthly income estimated at 70 US Dollars. Clinically, 123 patients (66.5%) were in WHO
stage III. The body mass index was over 18.5 kg/m2 in 124 patients (67%). The median number of TCD4 lymphocytes was
254.5 cells/ml and 25 patients (13.5%) had a number of CD4 over 500 cells/ml. HIV1 was really predominant (97.8%). Most
patients (152 or 82.2%) had been screened for clinical suspicion. Conclusion: HIV infection in Benin remains the prerogative
of young, female, educated and poor people. Screening is delayed and hence the need to develop innovative strategies for early
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Research Article
Hindawi
BioMed Research International
Volume 2018, Article ID 9619684, 10 pages https://doi.org/10.1155/2018/9619684
In aquaculture, antibiotics have been used mainly for therapeutic purposes and as prophylactic agents. The contribution to antimicrobial resistance of antibiotics used in aquaculture is reviewed here, using a risk analysis framework. Some recommendations on responsible conduct in this context are pr...oposed, aimed at diminishing the threat of build up of antimicrobial resistance.
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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 ...facing is refusals by parents and caregivers to immunise their children with the polio vaccine. In light of this challenge, the Pakistan programme has revisited its strategy and put forward this Extension of the National Emergency Action Plan 2018/2019 (NEAP), which will carry the programme forward from July to December 2019
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The World Health Organization (WHO) recommends the use of insecticide-treated nets (ITNs) and intermittent preventive treatment in pregnancy (IPTp) as a cost-effective intervention for the prevention of malaria during pregnancy in endemic areas. This study was conducted to investigate: (1) the exten...t of use of both IPTp and ITNs, and (2) conduct multinomial regression to identify factors affecting the optimal usage of IPTp and ITNs among women with a recent pregnancy in Senegal.
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Participant Manual September 2012
Surveillance of Populations at High Risk for HIV Transmission
Antimicrobial resistance represents a big threat to public health. The Centers for Disease Control and Prevention (CDC) estimate that every year two million Americans are infected with a (multi-)drug resistant bacterium, resulting in 23,000 deaths. The WHO has repeatedly drawn attention to this majo...r health issue. In the worst-case scenario, we will shortly run out of effective antibiotics. Surgery and cancer therapy will then become very dangerous due to the risk of infection associated with such treatments. (Organ) transplantation will become close to impossible as the immunosuppression necessary for transplant patients makes them highly vulnerable to infections. Some infections we can easily treat today could turn deadly. It is therefore conceivable that infectious diseases once again become the leading cause of death as in early 20th century.
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Comprehensive Reviews in Food Science and Food Safety, Vol.12 (2013) pp.234-248
In 2006, the Institute of Food Technologists (IFT) published an Expert Report entitled “Antimicrobial Resistance: Implications for the Food System” (IFT 2006). That report summarized current scientific knowledge pe...rtaining to the public-health impact of antimicrobial use in the food system and the development and control of antimicrobial resistance. Since that time, intense interest in this topic has continued within the regulatory and scientific communities as well as the general public. This IFT Scientific Status Summary serves to update that 2006 IFT Expert Report by briefly reviewing new scientific evidence relevant to the goals of the initial report and providing a number of key observations and conclusions.
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The purpose of this guidance is to assist WHO Member States, and other stakeholders, in the establishment and development of programmes of integrated surveillance of antimicrobial resistance in foodborne bacteria (i.e., bacteria commonly transmitted by food). In this guidance, “integrated surveill...ance of antimicrobial resistance in foodborne bacteria” is defined as the collection, validation, analyses and reporting of relevant microbiological and epidemiological data on antimicrobial resistance in foodborne bacteria from humans, animals, and food, and on relevant antimicrobial use in humans and animals. Integrated surveillance of antimicrobial resistance in foodborne bacteria therefore includes data from relevant food chain sectors (animals, food and humans) and includes data on both antimicrobial resistance and antimicrobial use. Integrated surveillance of antimicrobial resistance for foodborne bacteria expands on traditional public health surveillance to include multiple elements of the food chain, and to include antimicrobial use data, to better understand the sources of infection and transmission routes.
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Previous studies have highlighted a range of individual determinants associated with HIV testing but few have assessed the role of contextual factors. The objective of this paper is to examine the influence of both individual and community-level determinants of HIV testing uptake in Burkina Faso.
On the 31st December 2019, the World Health Organization (WHO) China country office reported a cluster of pneumonia cases in Wuhan City, Hubei Province of China now known to be caused by a novel virus. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been confirmed as the causative v...irus of Coronavirus disease 2019 (COVID-19). Cases have now been identified in over 100 countries including South Africa.
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The information contained in this document, be it guidelines, recommendations, diagnostic algorithms or treatment regimens, are offered in this document in the public interest. To the best of the knowledge of the guideline writing team, the information contained in these guidelines is correct. Imple...mentation of any aspect of these guidelines remains the responsibility of the implementing agency in so far as public health liability resides, or the responsibility of the individual clinician in the case of diagnosis or treatment.
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Версия: 2
Дата: 10 февраля 2020 г.
Протокол посвящен выявлению и отслеживанию пациентов и их близких контактов в общей массе населения либо в условиях локального рас...ространения (например, в домохозяйствах, медицинских, образовательных учреждениях). FFX - основной протокол исследования, который должен быть использован при выявлении первоначальных лабораторно подтвержденных случаев COVID-19 в стране.
Для более целенаправленного подхода к конкретным группам и более точной оценки эпидемиологических параметров доступны три других протокола исследований
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India reported its 1st case of COVID-19 on 30th January, 2020. It was a travel related case from Wuhan, China. Since then (as on 29th March, 2020), 979 confirmed cases and 25 deaths have been reported from 27 States/UTs. Although there is no evidence to widespread community transmission, 20 existing... and 22 potential hotspots have been identified. The containment measures to break the cycle of transmission and clinical management of those affected would require large human resource (HR).
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This guideline is based on the current epidemiological knowledge about the COVID-19. India is currently having travel related cases and few cases of local transmission. At this stage, all suspect/ confirmed cases will be isolated in a health care facility. Hence the document is limited in scope to h...ospital deaths.
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Pan African Medical Journal. 2016; 25:213 doi:10.11604/pamj.2016.25.213.88