In preparing this paper, the Pharmacovigilance Group of the Pan American Health Organization’s Pan American Network for Drug Regulatory Harmonization (PANDRH) adopted the perspective of PAHO/WHO, which considers Pharmacovigilance, an essential component of public health programs. Its intention was... to facilitate the development of pharmacovigilance systems in the Region of the Americas and improve, strengthen, and promote the adoption of good practices to improve safety for patients and the general population, based on the needs of the Region.
Document also available in Spanish and Portuguese!
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Disease Control Priorities, 3rdEdition: Volume 4.
Mental, neurological, and substance use disorders are common, highly disabling, and associated with significant premature mortality. The impact of these disorders on the social and economic well-beingof individuals, families, and societies is large..., growing, and underestimated
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This manual is designed primarily to assist managers of national malaria programmes and national reference laboratory responsible for quality assurance of malaria microscopy control. The information is also applicable to non-governmental organizations and funding agencies investing in quality manage...ment systems for malaria microscopy.
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A resource for pesticide registrars and regulators.
The WHO urged governments to restrict access to highly toxic pesticides used for self-poisoning . Other effective interventions include education, youth intervention programs and follow-up of people at risk—and better data. Only 80 out of 183 WH...O member states reported high-quality vital registration data in 2016
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Tuberculosis (TB) control in the African Region has evolved since the disease was declared a global emergency by the World Health Organization (WHO) in 1993. Member States have adopted and implemented successive global and regional strategies and resolutions, with demonstrable positive impacts on in...cidence, prevalence and mortality, albeit with variations across countries. By the end of 2015, the Region as a whole met the key Millennium Development Goal (MDG) target of halting and beginning to reverse TB incidence. However only 35 of the 47 Member States met the MDG target.
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under National Program for Prevention and Control of Cancer, Diabetes, CVD & Stroke (NPCDCS) in
12th five year plan (2012-17)
The WHO Framework Convention on Tobacco Control (WHO FCTC) is an evidence-based treaty that reaffirms the right of all people to the highest standard of health and was developed in response to the globalization of the tobacco epidemic. Member States of the WHO South-East Asia Region have made... attempts to implement the demand and supply reduction strategies for tobacco control as recommended by the treaty. While recognizing the need to accelerate implementation of the WHO FCTC in the Region, this document has been developed to support the Member States in implementing the treaty using a ‘PRACTICAL’ Approach which pertains to identified demand and supply reduction strategies under the treaty.
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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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With this World Health Day, WHO is drawing attention to a group of diseases that are spread by insects and other vectors, the heavy health and economic burdens they impose, and what needs to be done to reduce these burdens. Many of these diseases have been historically confined to distinct geographi...cal areas, but this situation has become more fluid due to a host of ills, including climate change, intensive farming, dams, irrigation, deforestation, population movements, rapid unplanned urbanization, and phenomenal increases in international travel and trade. The control of vector-borne diseases can make a major contribution to poverty reduction, as it precisely targets the poor
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January 2019
Non Communicable Disease Control Programme Directorate General of Health Services Health Services Division, Ministry of Health & Family Welfare
The WHO European Office for the Prevention and Control of Noncommunicable Diseases organized an expert meeting on monitoring of digital marketing of unhealthy products to children and adolescents in June 2018. Based on that meeting, this report aims to provide a tool to support Member States in moni...toring digital marketing of unhealthy products to children; the resulting tool – the so-called CLICK monitoring framework – is flexible and can be adapted to national context. The report also describes current digital marketing strategies, the challenges arising from current practices, and some policy options to tackle digital marketing to children and adolescents.
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A Meand to enhancing HIV prevention in key populations. This document has been developed out of the increasing need to set up standards and procedures to prevent and respond to violence against key populations.
Apart from implementation of TB infection Prevention and Control measures, treatment of those with active TB of the lungs is key in preventing the spread of the TB bacilli. The Public Health Act CAP 242, section 17 classify TB as notifiable infectious disease and under section 26 as part of preventi...on and control of infectious diseases, those exposed or suffer from the notifiable infectious diseases should be isolated in designated place and detained while taking medication until in the assessment of the Medical officer of health confirm that the person is free from infection or able to be discharged without danger to public health.
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In order to streamline and effectively control compounding of medicinal products in hospitals and pharmacies, these Guidelines for Production of Extemporaneous and Hospital Based Sterile Preparations has been crafted. The purpose of these guidelines therefore is to assist pharmacists in ...discharging their legal and professional obligations to patients in the area of extemporaneous dispensing. This guidance will help to assure the safe and appropriate preparation and supply of extemporaneously prepared medicinal products to patients, where
the supply of such products is necessary.
Extemporaneous and hospital based sterile preparations are critical for patients whose clinical needs cannot be met by registered medicinal products. The guidelines outline the principles and application of the concepts of Good Manufacturing Practice (GMP) requirements for premises, equipment, personnel, storage, quality management system, quality control, compounding processes as well as documentation.
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This guidance addresses rationale, risk-based scenarios, practical considerations prior to adoption of the self-testing products, quality assurance, safety and ethical considerations, and data management considerations for COVID-19 self-testing. The Africa CDC recommends the use of rapid antigen sel...f-testing within two key scenarios. The first includes testing for case identification within scenarios with a high risk of infection, including symptomatic cases and contacts of a confirmed case. The second scenario involves general screening within scenarios of low or unknown risk exposure allowing for self-care such as before gatherings with at-risk individuals and prior to participation in events involving members of different households. Within these scenarios, a positive test result indicates likelihood of current infection, while a negative test result indicates a lower risk of active infection, though it does not rule out infection altogether. All positive cases should be managed following the national COVID-19 management protocol of Member States.ssur
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