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1
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
Follow-up and tracing of tuberculosis patients who fail to attend their scheduled appointments in Cotonou, Benin: a retrospective cohort study
Serge Ade1, Arnaud Trébucq, Anthony D. Harries, Gabriel Ade, Gildas Agodokpessi, Prudence Wachinou, Dissou Affolabi, Sévérin Anagonou
BMC Health Services Research
(2016)
C2
Ade et al. BMC Health Services Research (2016) 16:5
Background: In the “Centre National Hospitalier de Pneumo-Phtisiologie” of Cotonou, Benin, little is known about
the characteristics of patients who have not attended their scheduled appo
...
intment, the results of tracing and the
possible benefits on improving treatment outcomes. This study aimed to determine the contribution of tracing
activities for those who missed scheduled appointments towards a successful treatment outcome.
Methods: A retrospective cohort study was carried out among all smear-positive pulmonary tuberculosis patients
treated between January and September 2013. Data on demographic and diagnostic characteristics and treatment
outcomes were accessed from tuberculosis registers and treatment cards. Information on those who missed their
scheduled appointments was collected from the tracing tuberculosis register. A univariate analysis was performed
to explore factors associated with missing a scheduled appointment
more
The global tripartite self-assessment survey of country progress in addressing antimicrobial resistance (AMR) is a component of a broader approach for monitoring and evaluation of the global action plan on AMR. This report analyses the results of the second tripartite self-assessment survey
HIV/AIDS Programme
Circumcision – consultative review of additional information, 12 August 2016
21 September 2016
October 2018
HIV testing services
This technical report presents the results of a cross-sectional survey conducted in Banja Luka, the Republika Srpska, Bosnia and Herzegovina, between July and August 2017, as part of the FEEDcities Project (Food Environment Description in cities – eastern Europe and central Asia). The aim of the r
...
eport 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.
more
Calls for greater implementation research (IR) capacity came in the wake of compelling evidence that implementation strategies are critically important for the dissemination and facilitation of evidence-informed policies and interventions to tackle noncommunicable diseases (NCDs), thereby improving
...
outcomes for both individuals and populations. However, at present, implementation of evidence-based interventions and policies is challenged by a gap in lack of academic research on how these cost–effective recommended interventions can be implemented in the context of local settings, especially those of low and middle-income.
more
The Ghanaian Cabinet approved the antimicrobial resistance (AMR)Policy and Implementation plan(hereafter referred to as the national action plan or NAP)in December 2017, whilst the country case study was in progress. This has set in motion the implementation phase for Ghana, which is a long awaited
...
event since the drafting of the Policy started in 2011. This case study, whilst limited in its ability to interact with all stakeholders, has identified entrypoints within the operational divisions of Ghana Health Services,as potential areas where the AMR policy platform may seek to embed AMR activities. Much work has already been done within Ghana to identify the key entrypoints within the various ministries and government agencieswhere AMR can be incorporated. These stakeholders already form part of the AMR Policy Platform which is the governance structure for AMR and have been participating actively in the development of the AMR Policy and NAP activities formulation.
more
The most significant finding of the case study for integrating antimicrobial resistance (AMR)into existing programs and mobilising resources for funding in Nigeria, is that most of the AMR activities within the Nigerian National Action Plan (NAP)canalready be incorporated within exi
...
sting programs of the Federal Ministry of Health (FMOH), Federal Ministry of Agriculture and Rural Development (FMARD) and their agencies or institutes. Certain programs and initiatives already have an AMR element incorporated or could,with little effort,include some additional AMR actions, however much is already being planned and has started with existing federal funding and existing staffing and other resources including development partner support and is being driven by significant political will from the ministries as well as implementation support from the Nigerian Centers for Disease Control as the focal point.
more
China is one of the major countries for the production and use of antibacterial agents. Antibacterial agents are widely used in healthcare and animal husbandry. It plays a significant role in treating infections and saving patient lives, preventing and treating animal diseases, improving farming ef
...
ficiency, and guaranteeing public health security. However, antimicrobial resistance has become increasingly prominent due to insufficient research and development capacity of new antimicrobials, sales of antimicrobials without prescriptions in pharmacies, irrational use of antibacterial agents in medical and food animal sectors, non-compliant waste emissions of pharmaceutical enterprises, as well as lack of public awareness toward rational use of antimicrobials. Bacterial resistance ultimately affects human health, but the cause of bacterial resistance and consequences are beyond the health sector. Antimicrobial resistance brings increasing biosecurity threats, worsens environmental pollution, constrains economic development and other adverse effects to human society, thus, there is an urgent need to strengthen multi-sectoral and multi-domain collaborative planning to jointly cope with this issue.
more
Vaccines are powerful weapons in the fight against pandemic viruses as shown by responses to both the 2009 H1N1 influenza and the COVID-19 pandemics. However, planning for accessing, allocating and deploying vaccines in a pandemic situation is a complex endeavour, beset with multiple challenges at a
...
ll levels – local, regional and global. The World Health Organization (WHO) and its partners have prepared this revised guidance document to assist countries update their national deployment and vaccination plans (NDVPs) by leveraging global learnings from past pandemic responses, including the recent COVID-19 vaccination effort. The development and testing of a NDVP would not only advance pandemic preparedness efforts but would also have benefits in terms of increasing national capabilities to manage other health emergencies which require emergency vaccination campaigns.
more
The WHO COVID-19 Clinical management: living guidance contains the Organization’s most up-to-date recommendations for the clinical management of people with COVID-19. Providing guidance that is comprehensive and holistic for the optimal care of COVID-19 patients throughout their entire illness is
...
important. The latest version of this living guideline is available in pdf format (via the ‘Download’ button) and via an online platform, and is updated regularly as new evidence emerges. No further updates to the previous existing recommendations were made in this latest version.
This updated (fifth) version contains 16 new recommendations for the rehabilitation of adults with post COVID-19 condition (see Chapter 24)
This updated (fourth) version contains three new recommendations regarding hospitalized patients with severe or critical COVID-19
more
The focus of the current quarterly edition of Eurohealth (from the European Observatory on Health Systems and Policies) is Antimicrobial Resistance (AMR) and contains the following articles:
• Strengthening implementation of AMR national ac
...
tion plans
• Fostering clinical development and commercialisation of novel antibiotics
• Tackling AMR in the community
• Quantifying the benefits of vaccines in combating AMR
more
This document provides guidance to Member States in the WHO European Region that wish to conduct behavioural insights studies related to COVID-19. Studies can be used to monitor public knowledge, risk perceptions, behaviours and trust with the overall aim to inform national COVID-19 outbreak respons
...
e measures, including policies, interventions and communications.
more
Policy brief, 24 July 2020
The COVID-19 pandemic has affected older people disproportionately, especially those living in long-term care facilities. In many countries, evidence shows that more than 40% of COVID-19 related deaths have been linked to long-term care facilities, with figures being as h
...
igh as 80% in some high-income countries. Concerted action is needed to mitigate the impact across all aspects of long-term care, including home- and community-based care, given that most users and providers of care are those who are vulnerable to severe COVID-19.
This policy brief provides 11 policy objectives and key action points to prevent and manage COVID-19 across long-term care. Its intended audience is policy makers and authorities (national, subnational and local) involved in the COVID-19 pandemic. The brief builds on currently available evidence on the measures taken to prevent, prepare for and respond to the COVID‑19 pandemic across long-term care services including care providers
more
General practitioners and pediatricians must know the signs and
symptoms of possible pediatric cancer.
This module is part of the WHO series The Immunological Basis for Immunization, which was initially developed in 1993 as a set of eight modules, comprising one module on general immunology and seven modules each devoted to one of the vaccines recommended for the Expanded Programme on Immunization, i
...
.e. vaccines against diphtheria, measles, pertussis, polio, tetanus, tuberculosis and yellow fever. Since then, this series has been updated and extended to include other vaccines of international importance. The main purpose of the modules is to provide national immunization managers and vaccination professionals with an overview of the scientific basis of vaccination against a range of important infectious diseases. The modules developed since 1993 continue to be vaccine-specific, reflecting the biological differences in immune responses to the individual pathogens and the differing strategies employed to create the best possible level of protection that can be provided by vaccination. The modules also serve as a record of the immunological basis for the WHO recommendations on vaccine use, published in the WHO vaccine position papers.*
more
This paper provides case studies of several food product improvement policies from across the WHO European Region. The aim is to share country experience, assess the various merits of the different approaches, discuss lessons learned, and provide guidance for best practice that may be more widely ap
...
plicable across the European Region.
more