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
Nature Reviews Microbiology Vol. 17 (2019)pp.51-62
Antimicrobial susceptibility testing (AST) technologies help to accelerate the
initiation of targeted antimicrobial therapy for patients with infections and could potentially
extend the lifespan of current narrow- spectrum antimicrobials. Althoug...h conceptually new and
rapid AST technologies have been described, including new phenotyping methods, digital
imaging and genomic approaches, there is no single major, or broadly accepted, technological
breakthrough that leads the field of rapid AST platform development
more
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
more
Antimicrobial resistance (AMR) both in human and veterinary medicine has reached alarming levels in
most parts of the world and has now been recognized as a significant emerging threat to global public
health and food security. In June 2015, the Food and Agriculture Organization of the United Nati...ons
(FAO) passed a resolution on AMR at its governing
Conference. This followed the adoption of counterpart
resolutions on AMR by The World Organisation
for Animal Health (OIE) and the World Health Organization
(WHO) in May 20152, and marked the
beginning of a joint effort by the three organizations
to combat AMR globally.
more
In recognition of the growing problem of antimicrobial resistance (AMR), its increasing threat to human, animal and plant health, and the need for a One Health approach to address this issue, the 39th Session of the Codex Alimentarius Commission (CAC) agreed it was important for the food safety comm...unity to play its part and re-established the ad hoc Codex Intergovernmental Task Force on Antimicrobial Resistance (TFAMR) ). The objectives of the Task Force were
to revise the current Codex Code of Practice to Minimise and Contain Antimicrobial Resistance and to develop new guidance on surveillance programmes relevant to foodborne AMR.
more
This publication describes an arduous campaign to tackle the use of antimicrobials - specifically antibiotics - in the Danish swine-producing sector thanks to the collaboration between the regulatory sector within the Ministry of Environment and Food, private veterinary practitioners and swine produ...cers. The document is a retrospective tribute to all those who had the foresight to make significant changes to ensure consumer protection - improving hygiene at primary sites, developing options for intervention, identifying sites for intervention, setting targets, restructuring the relationship between the veterinary services and farmers, and implementing changes in behaviour for greatest impact
more
The Antimicrobial Resistance Benchmark has evaluated for the second time how the most important players in the antibiotic market are addressing the rise of resistance and the global need for appropriate access to antibiotics. Although we can see progress — it’s hanging by a thread.
We have reac...hed a tipping point where large and prominent drugmakers have retreated from the antibiotics field and smaller innovative biotech companies have gone bankrupt due to the poor financial rewards on offer.
more
AMR is a serious and growing global problem. A WHO report released in 2014 stated that this serious threat is no longer a prediction for the future it is happening now in every region of the world and has potential to affect anyone, of any age in any community – a real threat to the public health.... The coming together of the various important stakeholders to develop this document is the testimony of their agreement of how serious is the issue at hand and their intentions to combat AMR is translated into an Action Plan. WHO also reported that there are about 2 million people in the US are infected with the AMR organism while 23,000 die annually from AMR infections. Fiji is just 10 hours journey away from the United States of America therefore Fiji must act now to keep our population safe from AMR organisms.
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
Overuse and misuse of antibiotics in animals and humans is contributing to the rising threat of antibiotic resistance. Some types of bacteria that cause serious infections in humans have already developed resistance to most or all of the available treatments, and there are very... few promising options in the research pipeline
more
Empfehlungen zur Umsetzung von Projekten in Fernsteuerung
Die Handreichung gibt einen Überblick über verschiedene Arten der Fernsteuerung. Sie zeigt Instrumente und Fallbeispiele auf, die NRO bei der Planung und Umsetzung solcher Projekte unterstützen.
Guinea’s 450 megawatt Souapiti dam, scheduled to begin operating in September 2020, is the most advanced of several new hydropower projects planned by the government of President Alpha Condé. Guinea’s government believes that hydropower can significantly increase access to electricity in a cou...ntry where only a fraction of people have reliable access to power.Souapiti’s output, however, has a human cost. The dam’s reservoir will ultimately displace an estimated 16,000 people from 101 villages and hamlets. The Guinean government had moved 51 villages by the end of 2019 and said it planned to conduct the remaining resettlements within a year. Forced off their ancestral homes and farmlands, and with much of their land already, or soon to be flooded, displaced communities are struggling to feed their families, restore their livelihoods, and live with dignity.
more
This primer aims to guide health professionals on engaging with WASH-related issues. It gives an overview of WASH interventions and the status of WASH services globally and outlines key linkages with health. It provides examples of key actions that health actors can take to ensure WASH efforts effec...tively protect public health and highlights World Health Organization (WHO) activities to support those actions.
more
The COVID-19 pandemic is having a profound negative effect on the global economy and is occurring in the context of a rapidly changing climate. This year is expected to be the second hottest in recorded history. Weather forecasts for 2020 indicate a high probability that extreme weather will adverse...ly affect food production in many countries. This brief draws on historical evidence and demonstrates that reductions in national food availability caused by severe weather events tend to be considerably larger in magnitude when they occur during global economic downturns. The risks posed by this dual threat are particularly high for poorer countries that are net food importers. Taking actions to mitigate these adverse effects in the short-term, while building the resilience of agri-food systems to future shocks is critical for avoiding major contractions in food availability and associated risks of food insecurity.
more
WHO published the first COVID-19 Strategic Response and Preparedness Plan (SPRP) on 3 February, 2020. This report highlights the main points of progress that were made up to 30 June 2020 under the three objectives outlined in the SPRP: scaling up international coordination and support; scaling up co...untry preparedness and response by pillar; and accelerating research and innovation. The report also discusses some of the key challenges faced so far, and provides an update on the resource requirements for the next phase of WHO’s response as part of an unprecedented whole-of-UN approach to the pandemic.
more