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
more
Effective Ebola risk communication requires respect and transparency and remains as vital
as ever. An assessment of changing communication needs and preferences in Beni, North Kivu.
In the second year of the current Ebola outbreak response in the Democratic Republic of Congo (DRC), people at ris...k still don’t have clear answers to their questions about the disease in a language they understand. Many local health communicators are themselves confused about the disease prevention and treatment measures they promote. The language, content, and form of communication about Ebola affect how far people understand, trust and act upon it.
more
Strengthening the capacities of SUN Countries by sharing and disseminating good practices in the fight against malnutrition.
This report is a summary of the results of the preparation and implementation of the Learning Route (LR) organized jointly by the SUN (Scaling Up Nutrition) Movement’s S...ecretariat, the Fight Against Malnutrition Unit (CLM, Cellule de Lutte contre la Malnutrition) and PROCASUR Corporation; this Learning Route was held in Senegal from the 26th of May to the 1st of June, 2014. The aim of this publication is to illustrate the experience, its main outcomes, and the lessons learned.
more
A role for nuclear techniques
Antimicrobials play a critical role in the treatment of human and animal (aquatic and terrestrial) diseases, which has led to their widespread application and use. Antimicrobial resistance (AMR) is the ability of microorganisms to stop an antibiotic, such as an antimic...robial, antiviral or antimalarial, from working against them. Globally, about 700 000 deaths per year arise from resistant infections as a result of the fact that antimicrobial drugs have become less effective at killing resistant pathogens. Antimicrobial chemicals that are present in environmental compartments can trigger the development of AMR. These chemicals can also cause antibiotic-resistant bacteria (ARB) to further spread antibiotic resistance genes (ARG) because they may have an evolutionary advantage over non-resistant bacteria.
more
To save the lives of mothers and their babies, mitigate complications, and limit the spread of disease, it is critical that recommendations are made on the prevention, treatment, and surveillance of women who are exposed to EVD, acquire EVD during pregnancy or breastfeeding, or survive EVD with ongo...ing pregnancies. These guidelines are the first to provide such recommendations.
more
This manual will contribute directly to the fourth focus area of the FAO Action Plan by promoting the prevention of infections and the prudent use of antibiotics in the pig and poultry sectors. The pig and poultry sectors are addressed together, as these sectors generally have the highest use of ant...ibiotics. This manual is jointly applicable to veterinarians, other health professionals and farmers; a key to success in using antibiotics effectively and prudently is good dialogue among these professions.
more
The CDAC Network commissioned a practice guide to draw both on their experiences and many others’ in order to document approaches, practices and tools to working with rumors. It is aimed primarily at humanitarian programme managers and field staff to provide them with practical tips on how to work... with rumors in their response programs in a way that is achievable amid competing demands.
Part One focuses on some of the theory behind rumors: the definition, nature and importance of rumors, and why we need to work with them.
Part Two explains the key steps and considerations to identifying and addressing rumous: listening, verifying and engaging.
Part Three examines different roles and responsibilities in working with rumous, and how anticipation, coordination and partnerships can enhance what you do.
more
Module 8
Site Planning
July 2017
Module 8: Site planning. This module is for people involved in organizing PrEP services at specific sites. It outlines the steps to be taken in planning a PrEP service and gives suggestions for personnel, infrastructure and commodities that could be considered... when implementing PrEP.
more
Module 12:
Adolescents and young adults
July 2018
Module 12: Adolescents and young adults. This module is for people who are interested in providing PrEP services to older adolescents and young adults who are at substantial risk for HIV. It provides information on: factors that influence HIV... susceptibility among young people; clinical considerations for safety and continuation on PrEP; ways to improve access and service utilization; and inclusive monitoring approaches to improve the recording and reporting of data on young people.
more
This document provides guidance on the application of non-pharmaceutical countermeasures to minimise the spread of the 2019 novel coronavirus (2019-nCoV) in the population. Some of the measures proposed refer specifically to certain phases of the epidemic (containment or mitigation phases), and can ...be adapted depending on the assessed severity/impact of the infection. Other measures are valid for all phases of an epidemic.
The guidance is based on the current knowledge of the 2019-nCoV and evidence available on other viral respiratory pathogens, mainly the Severe Acute Respiratory Syndrome coronavirus (SARS-CoV), the Middle East Respiratory Syndrome-related coronavirus (MERS-CoV) and seasonal or pandemic influenza viruses.
more
Évaluation du programme burkinabé dans les districts de Kaya et de Zorgho
Objectif. L’objectif central de cette thèse est d’évaluer, dans des conditions réelles d’implantation, les effets du programme burkinabé de prise en charge communautaire du paludisme sur le recours aux soins de...s enfants fébriles. Les objectifs spécifiques sont : (1) de sonder les perceptions des ASC à l’égard du programme et explorer les facteurs contextuels susceptibles d’affecter leur performance ; (2) d’estimer le recours aux ASC par les enfants fébriles et identifier ses déterminants ; (3) de mesurer, auprès des enfants fébriles, le changement des pratiques de recours aux soins induit par l’introduction d’une intervention concomitante – la gratuité des soins dans les centres de santé.
more
This handbook aims to help labour inspectors deal with the issue of HIV/AIDS.
It establishes the links between the key principles and core responsibilities of labour inspectorates and the management of HIV/ AIDS at the workplace.
It includes training activities and practical tools to help inspecto...rs integrate HIV/AIDS in their work.
more
Updated with information on Ebola virus disease and Middle East respiratory syndrome coronavirus
A wide variety of health events ranging in severity may occur related to air transport, requiring different responses or, perhaps, no response at all. The target audience for this guidance document incl...udes the national focal points (NFP) for the IHR and public health authorities at PoE, as well as national aviation regulatory authorities, airport operators and personnel, aircraft operators, air crew and other stakeholders involved in air transport and emergency preparedness and response to public health events
more
The animal health subsector within the agriculture sector is the gatekeeper of antimicrobial resistance (AMR) in livestock, aquaculture, animal products, and the immediate animal environment. In support of member countries taking responsibility for and moving forward with putting AMR monitoring and ...surveillance in place for the animal sector, the Food and Agriculture Organization of the United Nations Regional Office for Asia and the Pacific (FAO-RAP) developed a regional AMR surveillance framework, each pillar of which is complemented by a guideline to reinforce its progressive implementation. The first of this series, Volume 1: Monitoring and surveillance of antimicrobial resistance in bacteria from healthy food animals intended for consumption, is centered on healthy animals reaching consumers and on the protection of public health.
more
A regional guide for governments in Asia and the Pacific to review, update and develop policies to address antimicrobial resistance and antimicrobial use in animal production
Historically, the discovery of the sulfa drugs in the 1930s and the subsequent development of penicillin during World War II ushered in a new era in the treatment of infectious diseases. Infections that were common causes of death and disease in the pre-...antibiotic era - rheumatic fever, syphilis, cellulitis and bacterial pneumonia - became treatable, and over the next 20 years most of the classes of antibiotics that find clinical use today were discovered and changed medicine in a profound way. The availability of antibiotics enabled revolutionary medical interventions such as cancer chemotherapy, organ transplants and essentially all major invasive surgeries from joint replacements to coronary bypass. Antibiotics, though, are unique among drugs in that their use precipitates their obsolescence. Paradoxically, these cures select for organisms that can evade them, fueling an arms race between microbes, clinicians and drug discoverers.
Wright BMC Biology 2010, 8:123 http://www.biomedcentral.com/1741-7007/8/12
more
Productive and Inclusive Cities for an Emerging Democratic Republic of Congo