Licensed pharmaceutical products (marketing authorization) should be manufactured only by licensed manufacturers (holders of a manufacturing authorization) whose activities are regularly inspected by competent national authorities. This guide to GMP shall be used as a standard to justify GMP status,... which constitutes one of the elements of the WHO Certification Scheme on the quality of pharmaceutical products moving in international commerce, through the assessment of applications for manufacturing authorizations and as a basis for the inspection of manufacturing facilities. It may also be used as training material for government medicines inspectors, as well as for production, QC and QA personnel in the industry
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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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International Journal of Infectious Diseases 70 (2018) 121–130
https://doi.org/10.1016/j.ijid.2018.03.007
1201-9712/© 2018 The Authors. Published by Elsevier Ltd on behalf of International Society for Infectious Diseases. This is an open access article under the CC BY-NC-ND license (http://cr...eativecommons.org/licenses/by-nc-nd/4.0/).
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Provision of integrated RH/FP/STI/HIV services
In Togo, the limited access of populations, especially women, young girls and children to Reproductive Health (RH), Family Planning, treatment of sexually transmissible infections (STI) and struggle against HIV quality services is responsible for t...he continuously low indicators in these areas. To remedy the problem, UNFPA Togo, in partnership with the Department of Family Health, the Health districts and the NGOs 3ASC and ATBEF, support the initiative of the Mobile Clinic to bring RH/FP/STI/HIV quality services closer to the women, the young girls and children living in rural areas in its intervention areas, with the aim of reaching MDG 4 and 5.
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BMC Family Practice201415:165, DOI: 10.1186/1471-2296-15-165
Open Access
In health emergencies as in periods of stability, restoring access to primary health-care services is a priority in so far as many health problems can be dealt with by means of preventive care and
conventional therapy. Depending on the context, the ICRC must often take action in this area, taking i...nto account the level of emergency, the involvement of other actors, the possible evolution of the situation and the organization's operational strategies.
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The WHO Toolkit for the care and support of people affected by complications associated with Zika virus has been developed to serve as a model guide, with the goal of enhancing country preparedness for Zika virus outbreaks. The toolkit is intended to provide a systems approach involving public heal...th planners and managers so that the necessary infrastructure and resources can be identified and incorporated as needed, as well as technical and practical guidance for health care professionals and community workers.
The toolkit includes three manuals to provide countries with tools to effectively recognize people affected by Zika virus and deliver comprehensive care and support:
Manual for public health planners and managers
Manual for health care professionals
Manual for community workers
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PLoS ONE 7(12): e52986. doi:10.1371/journal.pone.0052986. Opern Access please download from the website
User satisfaction with assistive devices is a predictor of use and an important outcome measure. This study evaluated client satisfaction with prosthetic and orthotic assistive devices and services in three provinces in the Lao People’s Democratic Republic. Clients were quite satisfied with the as...sistive device and services provided, yet many reported barriers to optimal device use and difficulties in accessing follow-up services. There is a need to examine how prosthetic and orthotic devices can be improved further for better comfort and ambulation on uneven ground in low-resource contexts and to address access barriers.
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The project will support preventive actions, traditional medicine and the coordination and
implementation capacities of the national framework for HIV/AIDS control.
Lancet Glob Health 2015; 3: e396–409. Open Access
There is a crucial need to initiate and sustain fistula programs that increase access and strengthen the capacity of the health care system to provide high quality services for repair and care of women living with female genital fistula. Therefore, it is important to pay particular attention to the ...quality of training, and to proactively determine how this training fits into the health care system. Furthermore, the quality of training is improved by committing adequate resources to ensure competent trainers, able to train and follow-up their trainees. Women with genital fistulae, their families and the community need to have confidence in the health care system. It is therefore necessary to have pro-active discussions about the quality of training with relevant stakeholders. These fistula training guidelines and standards go towards harmonizing the training approach and to improving the quality of training and hence, service delivery.
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Lancet Glob Health 2015; 385: e387–95. Open Access
DOI:https://doi.org/10.1016/S2213-2600(20)30316-7
The Lancet Respiratory Medicine
Tis first edition describes the standard operating procedures for health products for NTDs amenable to preventive chemotherapy and the medicines donated to treat them. These include albendazole for lymphatic filariasis and soil-transmitted helminthiases; azithromycin for trachoma and yaws; diethylca...rbamazine citrate for lymphatic filariasis; ivermectin for onchocerciasis and lymphatic filariasis; mebendazole for soil-transmitted helminthiases; praziquantel for schistosomiasis; and triclabendazole for foodborne trematodiases. Standard operating procedures for diseases amenable to case management will be covered in subsequent editions, including the application process for requesting medicines (Chapter 1). In the meantime, the procedures described in the rest of the document apply for both case management and preventive chemotherapy NTD health products.
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The Global Antibiotic Resistance Partnership (GARP)-Mozambique team, in partnership with the Center for Disease Dynamics, Economics & Policy (CDDEP), has produced this report as part of a solid com-mitment to develop actionable policy proposals to tackle antibiotic resistance and improve appropriate... antibiotic access. It is the result of a thorough review of published and unpublished data on antibiotic resistance and a long internal consultation effort that engaged academic scientists, health professionals and other stakeholders within Mozambique.
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22 Sept. 2021
The rapid development of effective Covid-19 vaccines in 2020 gave hope to the world in the darkest days of the deadly pandemic. However, the vaccine roll-out has been massively skewed towards wealthy nations. While rich states have hoarded vaccines, companies have also played a decisi...ve role in restricting fair access to a life-saving health product. This report focuses on six leading vaccine developers, AstraZeneca, BioNTech, Johnson & Johnson, Moderna, Novavax and Pfizer, assessing each company’s human rights policy, pricing structure, records on intellectual property, knowledge and technology sharing, allocation of available vaccine doses and transparency.
Available in Arabic, English, French, German and Spanish
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