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Developed by the HHS Panel on Antiretroviral Therapy and Medical Management of Children Living with HIV—A Working Group of the Office
of AIDS Research Advisory Council (OARAC)
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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The extensive use of antimicrobials in human and veterinary medicine in recent years has accelerated the emergence and spread of resistant microorganisms. This situation has been worsened by the lack of investment in developing new effective antibiotics. The severity of the consequences is clear to ...see: it is estimated that each year, drug-resistant infections result in at least 25 000 patient deaths and cost the EU EUR 1,5 billion in healthcare costs and through loss of productivity
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Antimicrobial resistance (AMR) is a major global public health concern and a food safety issue. When pathogens become resistant to antimicrobial agents they can pose a greater human health risk as a result of potential treatment failure, loss of treatment options and increased likelihood and severi...ty of disease.
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Histoplasmosis is a disease caused by the fungus Histoplasma capsulatum. This disease is highly endemic in some regions of North America, Central America, and South America and is also reported in certain countries of Asia and Africa. It often affects people with impaired immunity, including people ...living with HIV, among whom the most frequent clinical presentation is disseminated histoplasmosis. The symptoms of disseminated histoplasmosis are non-specific and may be indistinguishable from those of other infectious diseases, especially disseminated tuberculosis (TB), thus complicating diagnosis and treatment. Histoplasmosis is one of the most frequent opportunistic infections caused by fungal pathogens among people living with HIV in the Americas and may be responsible for 5–15% of AIDS-related deaths every year in this Region. These guidelines aim to provide recommendations for the diagnosis, treatment, and management of disseminated histoplasmosis in persons living with HIV
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Guidelines on the management of chronic pain in children, developing and implementing national and local policies for pain management and protocols in children, implementing national and local regulations for pain management in children, pain management and protocols
This update of the Guidelines for poison control, entitled Guidelines for establishing a poison centre, reflects the development of the role of poison centres in public health and the sound management of chemicals, described in section 1, and the opportunities provided by new technology. Assessments... carried out under the IHR show
continuing gaps in capacity for managing chemicals (2). In particular, many countries still lack access to poison
centre services (3). There is therefore demand for updated guidance.
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Health Care Facilities (HCFs) are primarily responsible for management of the healthcare waste generated within the facilities, including activities undertaken by them in the community. The health care facilities, while generating the waste are responsible for segregation, collection, in-house trans...portation, pre-treatment of waste and storage of waste, before such waste is collected by Common Bio-medical Waste Treatment Facility(CBWTF) Operator. Thus, for proper management of the waste in the healthcare facilities the technical requirements of waste handling are needed to be understood and practiced by each category of the staff in accordance with the BMWM.
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Information for policy-makers and planners on conducting deworming as part of an integrated
school health program
This Pharmaceutical Country Profile for Kenya (2010) has been developed by the Ministry of Medical Services with support of the World Health Organization. The Profile contains information on existing socio-economic and health-related conditions, resources, regulatory structures and processes and out...comes relating to the pharmaceutical sector in Kenya.
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The Updated guidelines on Management of tuberculosis in children and adolescents include new recommendations that cover diagnostic approaches for TB, shorter treatment for children with non-severe drug-susceptible TB, a new option for the treatment of TB meningitis, the use of bedaquiline and delama...nid in young children with multidrug- and rifampicin-resistant TB and decentralized and family-centred, integrated models of care for TB case detection and prevention in children and adolescents.
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Expanding access to quality health services through task sharing
The Infection Prevention and Control (IPC) Guidelines aim to support healthcare workers improve quality and safety health care. The Guidelines further aim to promote and facilitate the overall goal of IPC by providing evidence-based recommendations on the critical aspects of IPC, focusing on the fun...damental principles and priority action areas. All health service organizations should consider the risk of healthcare-associated infection(s) (HAI) and antimicrobial resistance (AMR) transmission to implement these recommendations. The IPC Guidelines also set national standards for the prevention and control of HAIs and to ensure compliance to the National Quality Standards.
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