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 Access to Controlled Medications Programme identified the development of treatment guidelines that cover the treatment of all types of pain as one of the core areas of focus for improving access to opioid analgesics. Such guidelines are interesting both for health-care professionals and policy-...makers. They are also important in improving access to controlled medicines for determining when those opioid medicines and when non-opioid medicines are preferred.
Based on a Delphi study, WHO planned the development of three treatment guidelines, covering chronic pain in children, chronic pain in adults and acute pain.
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The Access to Controlled Medications Programme identified the development of treatment guidelines that cover the treatment of all types of pain as one of the core areas of focus for improving access to opioid analgesics. Such guidelines are interesting both for health-care professionals and policy-...makers. They are also important in improving access to controlled medicines for determining when those opioid medicines and when non-opioid medicines are preferred.
Based on a Delphi study, WHO planned the development of three treatment guidelines, covering chronic pain in children, chronic pain in adults and acute pain.
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Guidelines
UNAIDS/WHO working group on global HIV/AIDS and STI surveillance
August 2015
HIV strategic information for impact
Guide for clinical case management and infection prevention and control during ameasles outbreak. This guide has been developed to reduce the high morbidity and mortality seen in some of the current outbreaks of measles. This short guide outlines practical clinical care interventions and is derived ...from previously published WHO documents.
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USAID funded/ Primary Health Care Project in Iraq (PHCPI) in cooperation with Iraqi Ministry of Health (MOH) aims to promote Primary Health Care (PHC) services provided by Primary Health Care Clinics (PHCCs) in Iraq in order to achieve the development goal in enhancing the PHC provision system throu...gh achieving the following results: First: Enhancing management and operations systems, which support clinical care. Second: Improving the quality of the delivered PHC according to quality standards. Third: Enhancing and expanding local community participation and partnership in PHC. Maintaining the medical & service devices in the hospitals and health clinics besides making them function according to the adapted standard specifications, lead to providing most efficient medical services for people and accomplish the purposes for which they were invented. Maintenance and repair of facilities and infrastructure, and keeping them safe and clean are also of the important approaches for the results referred to in (first) and (second) above. This can be achieved through enhancing and developing facilities, and medical & service devices management. This guideline seeks to develop work mechanism for engineers, technicians and the PHCCs’ facilities and medical & service equipment maintenance workers; clarify the concept of maintenance, its importance and classifications in health area, its planning and implementation, the tasks and duties of other directorates and departments of the Ministry in relation to all kinds of maintenance. Add to that preparing documents and forms, which are used in documenting and monitoring the steps required to be accomplished in the maintenance of PHCCs’ facilities and medical & service equipment, for the equipment to perform the best possible services for people and get their satisfaction.
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This document provides a summary of infection control recommendations when providing direct and non-direct care to patients with suspected or confirmed Filovirus haemorrhagic fever (HF), including Ebola or Marburg haemorrhagic fevers. These recommendations are interim and will be updated when additi...onal information becomes available.
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Cases of human monkeypox are rarely seen outside of west and central Africa. There are few data regarding viral kinetics or the duration of viral shedding and no licensed treatments. Two oral drugs, brincidofovir and tecovirimat, have been approved for treatment of smallpox and have demonstrated eff...icacy against monkeypox in animals. Our aim was to describe the longitudinal clinical course of monkeypox in a high-income setting, coupled with viral dynamics, and any adverse events related to novel antiviral therapies.
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This manual provides guidance for policymakers on the issue of prehospital trauma care systems. The main areas covered include the organisation of the prehospital trauma care system, capacity development, data collection, transportation and communication, as well as ethical and legal considerations
Census Report Volume 4-C
The 2014 Myanmar Census provided the opportunity to measure maternal mortality. The questions on deaths in households during the twelve months prior to the Census were included in the questionnaire, as well as questions necessary to estimate maternal mortality indicator...s.
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This document outlines Rwanda's policy on non-communicable diseases. The overall goal of NCDs Policy is to alleviate the burden of NCDs and their risk factors and protect Rwandan population from premature morbidity and mortality related to NCDs. This policy was developed through a series of consulta...tive meetings and workshops of NCDs' core team members of MOH and RBC, National Technical Working Group (TWG), all implementing and non implementing partners and other development partners. This policy was developed in line with the Millennium Development Goals (MDGs), Vision 2020, Rwanda Economic Development Poverty Reduction Strategy (EDPRS II) of 2013-18 and NCDs Global Action Plan 2013-2020 and national Health Policy. This policy focuses on of the following NCDs: Cardiovascular diseases, Chronic Pulmonary Diseases (CPD), Cancers, Diabetes, injuries and disabilities, oral, eye and kidney diseases.
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As part of our commitment to the fight against NCDs, Nigeria was signatory to the political declaration at the UN General Assembly High Level Meeting on NCDs in September 2011. Thus, the purpose of this document is to develop and ensure the implementation of policies and p...rogrammes that will engender and guarantee a healthy lifestyle and quality health for all Nigerians. The core sections include background, scope of the policy, policy goal, strategic thrusts for implementation, programme management and coordination, roles of stakeholders and partnership coordination. It is expected that with the adoption of this policy, the control and prevention of NCDs and their associated risk factors will be well integrated at all levels of government and health care delivery system in Nigeria. This policy document is therefore a stepping stone towards the development of guidelines for the prevention and management of NCDs.
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This brief considers the rationale for shielding individuals at high risk of severe disease or death from COVID-19 in low- and middleincome countries. It provides an overview of proposed approaches to shielding, discusses the categories of individuals who may be identified for shielding, and outline...s the likely difficulties of these measures and ways to mitigate them.
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