Quality Assurance (QA) and Quality Improvement (QI). The guide provides general information on how to organize, implement and follow up on quality assurance/quality improvement clinical facility and service assessments. At the website you will find checklists intended to be used with the clinical fa...cility assessment guide
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"Achieving, maintaining and improving accuracy, timeliness and reliability are major challenges for health laboratories. Countries worldwide committed themselves to build national capacities for the detection of, and response to, public health events of international concern when they decided to eng...age in the International Health Regulations implementation process. Only sound management of quality in health laboratories will enable countries to produce test results that the international community will trust in cases of international emergency. This handbook is intended to provide a comprehensive reference on Laboratory Quality Management System for all stakeholders in health laboratory processes, from management, to administration, to bench-work laboratorians. This handbook covers topics that are essential for quality management of a public health or clinical laboratory. They are based on both ISO 15189 and CLSI GP26-A3 documents"--Page 7.
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The objective of this briefis to set outlinkages between food safety and the Sustainable Development Goals(SDGs), to identify priority issues,and to suggest how investments in food safety can help attain SDGs.
The report is geared towards mayors, local government officials and city policy planners.It highlights key areas where city leaders can tackle the drivers of NCDs, including tobacco use, air pollution, poor diets and lack of exercise, and improve road safety.
From anti-tobacco actions in Beijing a...nd Bogor, to road safety initiatives in Accra and Bangkok, a bike sharing scheme in Fortaleza, and actions to create walkable streets for seniors that have reduced elderly pedestrian deaths by 16% in New York City, the report aims to share knowledge between urban policy planners.
Of the 19 case studies cited, 15 are from developing countries, where 85% of premature adult deaths through NCDs take place, and over 90% of road traffic fatalities are recorded. You can download the case studieson the website https://www.who.int/ncds/publications/tackling-ncds-in-cities/en/.
Over 90% of future urban population growth will be in low or middle-income countries, and seven of the world’s 10 largest cities are in developing countries.
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Original text from 2008, updated in 2012. This document marks the beginning of a structured approach to safety assessment of GE foods, which are yet to be approved in our country. It is understood that many changes will become necessary and will be incorporated as we progress. This document will ho...wever, remain an important milestone in the process towards safety evaluation of food derived from GE plants in India.
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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
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Reporting system for the general public - This document aims to provide practical guidelines on how to set up national systems for consumers to report adverse reactions to medicines. The purpose is to help countries set up a well-organized and effective consumer reporting system within their pharmac...ovigilance centre. Throughout this document, the phrase “consumer reporting” is used to refer to reporting of adverse drug reactions (ADRs) by the general public.
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To provide quality maternal and newborn health services at health facilities in India.
The safety of medicines in Zambia - why health workers need to take action | Produced by the National Pharmacovigilance Unit (NPVU)
In recognition of the growing problem of antimicrobial resistance (AMR), its increasing threat to human, animal and plant health, and the need for a One Health approach to address this issue, the 39th Session of the Codex Alimentarius Commission (CAC) agreed it was important for the food safety comm...unity to play its part and re-established the ad hoc Codex Intergovernmental Task Force on Antimicrobial Resistance (TFAMR) ). The objectives of the Task Force were
to revise the current Codex Code of Practice to Minimise and Contain Antimicrobial Resistance and to develop new guidance on surveillance programmes relevant to foodborne AMR.
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The second ECDC/EFSA/EMA joint report on the integrated analysis of antimicrobial consumption (AMC) and antimicrobial resistance (AMR) in bacteria from humans and food-producing animals addressed data obtained by the Agencies’ EU-wide surveillance networks for 2013–2015. AMC in both sectors, exp...ressed in mg/kg of estimated biomass, were compared at country and European level. Substantial variations between countries were observed in both sectors. Estimated data on AMC for pigs and poultry were used for the first time. Univariate and multivariate analyses were applied to study associations between AMC and AMR. In 2014, the average AMC was higher in animals (152 mg/kg) than in humans (124 mg/kg), but the opposite applied to the median AMC (67 and 118 mg/kg, respectively). In 18 of 28 countries, AMC was lower in animals than in humans. Univariate analysis showed statistically-significant (p < 0.05) associations between AMC and AMR for fluoroquinolones and Escherichia coli in both sectors, for 3rd- and 4th-generation cephalosporins and E. coli in humans, and tetracyclines and polymyxins and E. coli in animals. In humans, there was a statistically-significant association between AMC and AMR for carbapenems and polymyxins in Klebsiella pneumoniae. Consumption of macrolides in animals was significantly associated with macrolide resistance in Campylobacter coli in animals and humans. Multivariate analyses provided a unique approach to assess the contributions of AMC in humans and animals and AMR in bacteria from animals to AMR in bacteria from humans. Multivariate analyses demonstrated that 3rd- and 4th-generation cephalosporin and fluoroquinolone resistance in E. coli from humans was associated with corresponding AMC in humans, whereas resistance to fluoroquinolones in Salmonella spp. and Campylobacter spp. from humans was related to consumption of fluoroquinolones in animals. These results suggest that from a ‘One-health’ perspective, there is potential in both sectors to further develop prudent use of antimicrobials and thereby reduce AMR.
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This poster is intended for health workers and other personnel on the safety and mitigation measures that need to be adhered to when dealing with medical oxygen. Medical oxygen, either in liquid or gas form, is an oxidizing agent that can result in a fire or explosion if not handled properly.
Pharmaceutical regulators are at the forefront of ensuring that only safe and effective medicines are authorized and available in the market. This document builds on the recommendations in the above publication and has been prepared to specifically assist national medicines regulatory authorities to... understand the nature and extent of oxytocin quality issues and to provide key technical information and quality requirements for oxytocin products in dossier assessments. Furthermore, this document also presents recommendations on other regulatory actions needed to ensure that only quality-assured oxytocin products are authorized and made available to women.
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Compliance with the standards is monitored as part of our Quality Improvement Program.
Practitioner refers to physicians or other health professionals who provide health care services.
This guideline aims to improve the quality of donations and the management thereof and serve as the basis for policies of the State and other organizations in the giving and receiving of donations of medicines, medical devices and IVDs.
Over the last three or four decades, there has been an enorm...ous increase in scientific knowledge about the mode of action, effects and side effects of medicines, medical devices and IVDs. It is important for all
stakeholders to understand that these products have both benefits and risks, that they have to be used carefully and appropriately and that some can do more harm than good.
There are many different scenarios for the donation of medicines, medical devices and IVDs. Donations may take place in acute emergencies or as part of development aid in non-emergency situations. They may involve donations (i.e. direct or through private voluntary organizations), aid by governments or persons authorized to sell medicines, medical devices and/or IVDs.
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IAEA Safety Standards for protecting people and the environment
IAEA Safety Standards for protecting people and the environment
IAEA Safety Standards for protecting people and the environment
Patient safety standards are critical for the establishment and assessment of patient safety programmes within hospitals. This third edition of the Patient safety assessment manual provides an updated set of standards and assessment criteria that reflect current best practice and WHO guidance. The m...anual will support the implementation of patient safety assessments and improvement programmes within hospitals as part of the Patient Safety Friendly Hospital Framework to ensure that patient safety is prioritized and facilities and staff implement best practices. The manual is a key tool for use by professional associations regulatory accrediting or oversight bodies and ministries of health to improve patient safety.
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Lack of trained providers capable of identifying which labouring women could benefit from assisted vaginal birth (AVB), and of safely performing the procedure is a major barrier for its use. Education and training are, therefore, considered crucial for building skills and confidence in conducting AV...B and there is evidence that it would be welcomed by healthcare providers. However, acquiring and maintaining AVB skills is a complex task that requires a supportive environment, mentorship, supervision and accountability. As with other practices to manage infrequent procedures and complications, continuous education and on-site supervision are essential to ensure the safe and sustainable use of AVB.
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