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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
• Jacqueline Sawyer
• Iveta Streipa
D-Building – UNAIDS
Kofi A. Annan Meeting Room
Wednesday, 9 March 2016 11:15 – 11:30
more
Pakistan Global Antibiotic Resistance Partnership (GARP) was formed in the wake of international and national efforts for AMR curtailment. A group of experts from microbiology, infectious diseases and veterinary medicine
...
formed a core group at the organizational meeting of GARP in Kathmandu, Nepal in July 2016. In the meeting, this core group was expanded to include other members from different sectors with the selection of the Chair and co-chairs. These were asked to serve on a voluntary basis, in their own individual capacities, with no personal gains, or gains to the institutions to which they are affiliated. The first phase of GARP took place from 2009 to 2011 and involved four countries: India, Kenya, South Africa and Vietnam. Phase one culminated in the 1st Global Forum on Bacterial Infections, held in October 2011 in New Delhi, India. In 2012, phase two of GARP was initiated with the addition of working groups in Mozambique, Tanzania, Nepal and Uganda. Phase three has added Bangladesh, Lao PDR, Nigeria, Pakistan and Zimbabwe to the network to date.
more
This technical report describes the results of a cross-sectional survey conducted in Dushanbe, Tajikistan, between April and May 2016, as part of the FEEDcities Project – Eastern Europe and Central Asia. The aim was to describe the local street food environment: the characteristics of the vending
...
sites, the food offered and the nutritional composition of the industrial and homemade foods usually consumed in these settings.
The study was part of a bilateral partnership between WHO and the Institute of Public Health of the University of Porto, Portugal, in collaboration with the Faculty of Medicine, the Faculty of Nutrition and Food Sciences and the Faculty of Pharmacy of the University of Porto (WHO registration numbers 2015/591370 and 2017/698514).
more
Drivers, Dynamics and Epidemiology of Antimicrobial Resistance in Animal Production
B.A. Wall, A. Mateus, L. Marshall et al.
Food and Agriculture Organization of the United Nations FAO
(2016)
C2
Antimicrobial resistance (AMR) both in human and veterinary medicine has reached alarming levels in
most parts of the world and has now been recognized as a significant emerging threat to global public
health and food security. In June 2015, the F
...
ood and Agriculture Organization of the United Nations
(FAO) passed a resolution on AMR at its governing
Conference. This followed the adoption of counterpart
resolutions on AMR by The World Organisation
for Animal Health (OIE) and the World Health Organization
(WHO) in May 20152, and marked the
beginning of a joint effort by the three organizations
to combat AMR globally.
more
This was a Phase 3, multi-center, randomized, open-label, parallel-group, active control study where 273 male and female patients with first stage Trypanosoma brucei gambiense HAT were treated at six sites: one trypanosomiasis reference center in Angola, one hospital in South Sudan, and four hospita
...
ls in the Democratic Republic of the Congo between August 2005 and September 2009 to support the registration of pafuramidine for treatment of first stage HAT in collaboration with the United States Food and Drug Administration. Patients were treated with either 100 mg of pafuramidine orally twice a day for 10 days or 4 mg/kg pentamidine intramuscularly once daily for 7 days to assess the efficacy and safety of pafuramidine versus pentamidine. Pregnant and lactating women as well as adolescents were included.
more
This technical report contains the results from the FEEDcities Project – Eastern Europe and Central Asia, a cross-sectional survey of the local urban food environment conducted in Chișinău, Republic of Moldova between June and August 2016. It characterizes the vending sites, the food offered and
...
the nutritional composition of both industrial and homemade street foods. It also describes the nutritional composition of foods sold in supermarkets and fast-food outlets.
The study was conducted within a bilateral partnership between the World Health Organization and the Institute of Public Health of the University of Porto, in collaboration with the Faculty of Medicine, the Faculty of Nutrition and Food Sciences and the Faculty of Pharmacy of the University of Porto (WHO registration 2015/591370 and 2017/698514). The study was funded through a voluntary contribution of the Ministry of Health of the Russian Federation.
more
This technical report presents the results of a cross-sectional survey conducted in Sarajevo, the Federation of Bosnia and Herzegovina, Bosnia and Herzegovina, between June and August 2017, as part of the FEEDcities Project (Food Environment Description in cities – eastern Europe and central Asia)
...
. The aim of the report is to describe the city’s local street food and takeaway food environment, exploring the characteristics of food vending sites, the industrially produced and homemade foods they typically offer, and the nutritional composition of these foods. Finally, the report provides guidance on how to address its findings through policy action.
The study was conducted through a bilateral partnership between the World Health Organization (WHO) and the Institute of Public Health of the University of Porto, in collaboration with the Faculty of Medicine, the Faculty of Nutrition and Food Sciences, the Faculty of Pharmacy of the University of Porto (WHO registration 2015/591370 and 2017/698514) and the Institute of Public Health of the Federation of Bosnia and Herzegovina. The study was funded through a voluntary contribution of the Ministry of Health of the Russian Federation, and through a contribution made by the Swiss Agency for Development and Cooperation (SDC)/Swiss Government to a joint WHO/SDC project, “Reducing Health Risk Factors in Bosnia and Herzegovina: Developing and Advancing Modern and Sustainable Public Health Strategies, Capacities and Services to Improve Population Health”, implemented in Bosnia and Herzegovina.
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This technical report presents results from the FEEDcities Project – Eastern Europe and Central Asia, a cross-sectional survey conducted in Almaty, Aktau and Kyzylorda, Kazakhstan, between July and August 2017, to evaluate the local street food environment. It characterized the vending sites, the
...
food offered and the nutritional composition of the industrial and homemade foods available in these settings. The policy implications of the findings are outlined.
The study was conducted within a bilateral partnership between WHO and the Institute of Public Health of the University of Porto, in collaboration with the Faculty of Medicine, the Faculty of Nutrition and Food Sciences and the Faculty of Pharmacy of the University of Porto (WHO registration 2015/591370 and 2017/698514). The study was funded through a biennial collaborative agreement and joint programmes between the Government of Kazakhstan and United Nations agencies in Kazakhstan for Kyzylorda and Mangystau oblasts, a voluntary contribution by the Ministry of Health of the Russian Federation and the Resolve to Save Lives project of Bloomberg Philanthropies.
more
Prompt, effective antimalarial treatment, and supportive care can substantially reduce the rate of mortality from severe malaria. However, many children in malaria-endemic countries do not have access to health facilities or a qualified health care provider and do not receive the necessary care in a
...
timely fashion. Without rapid detection of danger signs and access to effective treatment, including pre-referral treatment that can be administered in the community level, many of these children with severe malaria die.
In situations where there is no immediate access to a health care facility, WHO recommends the administration of a standard dose of an effective antimalarial medicine as pre-referral treatment before referral to a facility at which complete treatment can be administered.
Rectal artesunate is the WHO-recommended pre-referral intervention in situations where artesunate injection are not feasible for children under the age of 6 years with suspected severe malaria. The intervention reduces the risk of death or permanent disability by up to 50% provided the child is referred to a health facility at which complete treatment can be administered.
This field guide is aimed at supporting the effective deployment of RAS as pre-referral treatment of suspected severe malaria in line with the WHO malaria guidelines.
more
As of June 2019, the number of Venezuelans leaving their country reached 4 million, with Colombia, Peru, Chile, Ecuador and Brazil hosting the vast majority of Venezuelans in Latin America. The end of the first half of the year was marked by the announcement of tighter immigration measures in Peru
...
and Chile, which triggered a significant peak in flows from Venezuela entering Colombia, Ecuador and Peru. In response to this, UNICEF Country Offices activated contingency measures and capacities for registration and provision of services were rapidly increased, in coordination with relevant authorities, to face the increased demand.
more
This document provides additional guidance for the responsible and prudent use of antimicrobials in food-producing animals, and should be read in conjunction with the Recommended International Code of Practice for Control of the Use of Veterinary Drugs CAC/RCP 38-1993. Its obj
...
ectives are to minimize the potential adverse impact on public health resulting from the use of antimicrobial agents in food-producing animals, in particular the development of antimicrobial resistance. It is also important to provide for the safe and effective use of veterinary antimicrobial drugs in veterinary medicine by maintaining their efficacy. This document defines the respective responsibilities of authorities and groups involved in the authorization, production, control, distribution and use of veterinary antimicrobials such as the national regulatory authorities, the veterinary pharmaceutical industry, veterinarians, distributors and producers of food-producing animals.
more
Action Plan for Implementation of Recommendations from the Evaluation of PAHO's Response to COVID-19
An external team evaluated PAHO’s response to COVID-19 to provide an independent assessment of the Pan American Sanitary Bureau’s (PASB) performance regarding preparedness for and response to the COVID-19 pandemic. The evaluations’ final report culminates with eight recommendations for actions
...
to future response to health emergencies. The final report of EPRC culminates with eight evidence-based recommendations of actions to strengthen future pandemic responses, while building a resilient recovery in the Region. The recommendations by the external team focus on PAHO’s governance and management, on specialized regional mechanisms, diversified funding models, and use of new technologies, among others.
more
The Ethiopian Food and Drug Administration (EFDA) is mandated, in the proclamation 661/2009, to ensure the safety, quality and efficacy of medicines. To achieve this, the authority has been working on different regulatory activities. The medicine ma
...
rket authorization system is one of the top priority areas that have been implemented. In addition to the dedicated assessors, the authority uses a national drug advisory committee for the assessment and registration of medicines.
more
Population size estimate of people who inject drugs (PWID) in the Republic of Kazakhstan
Ganina L.Yu; Yelizaryeva A. V.; Saparbekov M. K.; et al.
Ministry of Health and Social Development of the Republic of Kazakhstan Republican Center for AIDS Prevention and Control
(2016)
C2
Report
Almaty, 2016
Authors: Ganina L.Yu., head of epidemiology department, Republican AIDS Center (RAC), Yelizaryeva A. V., epidemiologist, RAC, Kaspirova А. А., head of epidemiology department, Aktobe Oblast AIDS center, IvakinV.Yu., deputy regional director for strategic information, ICA
...
P, KryukovaV.А., Strategic Information Specialist for Kazakhstan, ICAP, Abishev A. T., acting director general, RAC.
Edited by Saparbekov M. K., Doctor of Medical Science, Professor, Head of the Department of Epidemiology and Hygiene Faculty of Medicine – GSPH KazNU n.a. Al-Farabi, Almaty c.
more
This evaluation is the fifth in a series of structured evaluations of CFS and was completed as part of three-year collaboration with World Vision and Columbia University. It was conducted with Syrian refugees in an urban setting in Zarqa, Jordan during the months of February to August 2014. The CFS
...
was implemented through partners and supported and monitored by World Vision Jordan. Interviews were conducted during a one-week registration period hosted by partner staff and preceded by awareness campaigns in the community. Measurement tools were selected to assess impact in three areas in line with the programme’s key objectives: (a) the protection of children from risk, (b) supporting caregivers and communities in strengthening systems of child protection, and (c) the promotion of children’s psychosocial wellbeing (including the acquisition of skills and knowledge).
more
Clinical Medicine
JCI Insight. 2017;2(7):e91963.
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 health prof
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essionals, 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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Digital Comprehensive Summaries of Uppsala Dissertations from the Faculty of Medicine | The aim of this study was to explore the risk factors for stillbirth and neonatal death and change in perinatal outcomes after the introduction of helping Babies
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Breathe Quality Improvement Cycle in Nepal.
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Background: Cardiovascular disease (CVD), mainly heart attack and stroke, is the
leading cause of premature mortality in low and middle income countries (LMICs).
Identifying and managing individuals at high risk of CVD is an important strategy to prevent and control CVD, in addition to multisector
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al population-based interventions to reduce CVD risk factors in the entire population.
Methods: We describe key public health considerations in identifying and managing individuals at high risk of CVD in LMICs.
Results: A main objective of any strategy to identify individuals at high CVD risk is to maximize the number of CVD events averted while minimizing the numbers of
individuals needing treatment. Scores estimating the total risk of CVD (e.g. ten-year risk of fatal and non-fatal CVD) are available for LMICs, and are based on the main CVD risk factors (history of CVD, age, sex, tobacco use, blood pressure, blood cholesterol and diabetes status). Opportunistic screening of CVD risk factors enables identification of persons with high CVD risk, but this strategy can be widely applied in low resource settings only if cost effective interventions are used (e.g. the WHO Package of Essential NCD interventions for primary health care in low resource settings package) and if treatment (generally for years) can be sustained, including continued availability ofaffordable medications and funding mechanisms that allow people to purchase medications without impoverishing them (e.g. universal access to health care). Thisalso emphasises the need to re-orient health systems in LMICs towards chronic diseases management.
Conclusion: The large burden of CVD in LMICs and the fact that persons with high
CVD can be identified and managed along cost-effective interventions mean that
health systems need to be structured in a way that encourages patient registration, opportunistic screening of CVD risk factors, efficient procedures for the management of chronic conditions (e.g. task sharing) and provision of affordable treatment for those with high CVD risk. The focus needs to be in primary care because that is where most of the population can access health care and because CVD programmes can be run effectively at this level.
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