Most regulatory and quality professionals can think of a time when they struggled to find a specific requirement in the EU Medical Device Regulation (MDR). Finding all the instances where a particular compliance theme is mentioned can be painstaking and time-consuming. To allow easier navigation of the MDR, RQM+ has created a tool that allows users to search the legislation for specific subject areas.
The company’s internal specialists, as well as regulatory professionals within client companies, now save considerable administrative time every day by using the tool to consult the regulation. The tool enables quick searches by topic, chapter, article, and search term. Rather than highlighting or sticky noting a paper copy, users can save notes on company interpretations of MDR sections and even individual sentences in the tool itself.
The regulatory and quality consulting firm has already shared an IVDR filtering tool, to support manufacturers working towards the EU’s upcoming In Vitro Diagnostic Regulation (IVDR). Both the IVDR and MDR tools are now freely available for medical device professionals to download and consult for their daily work.
Dr. Jaishankar Kutty, Vice President of Clinical Services at RQM+, said: “I was recently introduced to this tool after joining RQM+ this February, and my first reaction was: it would’ve been wonderful to have this tool when we waded into the initial MDR reviews at BSI! More than any other stakeholder, Notified Bodies need to know the regulation inside-out, and this tool makes it so easy to double check requirements. It’s now sitting on my desktop for easy access and it has been an extremely useful and welcome support so far.”
Nancy Morrison, Executive Director, Regulatory & Quality Consulting Services, initially developed these tools to support the RQM+ team. “We refer to regulation on a daily basis so we’re well aware of the frustrations of trying to find specific details or to gather all the sections referring to an area of compliance. We help our clients to put in place clear and organized processes to facilitate both short- and long-term compliance, and I hope that these tools will also make the work of regulatory professionals a little more straightforward.”
Dr Tedros Adhanom Ghebreyesus, addressed the World Health Summit in Berlin on 24 October. This is what he had to say:
More than a decade ago, I was invited to be part of a group with an exciting new idea – an idea to bring together leaders from research, medicine, government, industry and global health, to ask the big questions and, hopefully, to make some progress towards big answers.
That first World Health Summit, in 2009, was held in the immediate aftermath of the global financial crisis, and in the shadow of the H1N1 pandemic.
In the 12 years since then, the World Health Summit has become a landmark on the global health calendar.
That’s why, together with Professor Axel Pries, we have decided to join forces to organize a joint World Health Summit in October 2022, to engage an even broader group of actors, committed to multilateral action for global health.
12 years since the first World Health Summit, we meet once again in the shadow of a pandemic.
And we are faced once again with some very big questions: some of the same ones we were asking in 2009 that remain unanswered, and some new ones.
When will the pandemic end?
One of the questions I am asked most often is: when will the pandemic end?
My answer is that the pandemic will end when the world chooses to end it. It’s in our hands.
We have all the tools we need: effective public health tools, and effective medical tools.
But the world has not used those tools well.
With almost 50 thousand deaths a week, the pandemic is far from over – and that’s just the reported deaths.
As you know, we have set a target to vaccinate 40% of the population of every country by the end of this year.
That target is reachable, but only if the countries and companies that control supply match their statements with actions – right now.
The barrier is not production. The barriers are politics and profit.
It’s clear what needs to happen:
The countries that have already reached the 40% target – including all G20 countries – must give their place in the vaccine delivery queue to COVAX and the African Vaccines Acquisition Trust, or AVAT;
The G20 countries must fulfil their dose-sharing commitments immediately;
Manufacturers must prioritize and fulfil their contracts with COVAX and AVAT as a matter of urgency, and be far more transparent about what is going where.
And they must share know-how, technology and licences, and waive intellectual property rights.
We’re not asking for charity; we’re calling for a common-sense investment in the global recovery.
How will we prevent this happening again?
The second major question the pandemic is asking us is, how will we prevent this happening again? How do we make the world safer?
In its first report in 2019, the Global Preparedness Monitoring Board warned that the world was unprepared for a pandemic, just months before COVID-19 struck.
We welcome the GPMB’s latest report, which will be launched on Tuesday, and its recommendations.
Allow me to offer four answers; four areas in which the global health architecture must be strengthened.
First, governance
For the past 20 years, the response to every crisis or health threat has been to create a new institution or mechanism, with new governance structures, and new funding needs.
The result is a global health architecture that is complex and fragmented.
That’s why we believe the time has come for a legally-binding international agreement on pandemic preparedness and response, which will be the focus of next month’s Special Session of the World Health Assembly.
Second, financing
Cycles of panic and neglect have created a financing ecosystem that is insufficient, inefficient and inequitable.
It’s clear that we need a substantial increase in funding for national and global preparedness and response.
Crucially, any new financing facilities must be built using existing financial institutions, rather than creating new ones that further fragment the global health architecture.
More broadly, it’s clear that we need a new narrative for the way health is financed, which is why earlier this year we established the Council on the Economics of Health for All, led by Professor Mariana Mazzucato. We look forward to the launch of its second policy brief on Tuesday.
Third, systems and tools
COVID-19 has exposed serious gaps in the global ability to prepare for, prevent, detect and respond rapidly to outbreaks with epidemic and pandemic potential.
We need new tools, across the One Health spectrum.
WHO has already taken steps to build some of those tools, including the new Hub for Epidemic and Pandemic Intelligence here in Berlin, which I had the honour to open with Chancellor Merkel last month.
Last month, I also had the honour of joining President Macron to break ground on the new WHO Academy in Lyon, which will be a state-of-the-art school, using cutting edge technologies to support lifelong learning for health workers and public health professionals around the world.
Other initiatives are in development.
And fourth, WHO itself
Beyond the response to COVID-19, WHO continues to respond to dozens of other emergencies around the world, to support countries to address the burden of communicable and noncommunicable diseases, and to address the social, economic and environmental determinants of health.
Earlier this month, we recommended broad use of the world’s first malaria vaccine, a new tool against an old disease that could save millions of lives;
On polio, only two cases have been reported in Afghanistan and Pakistan so far this year, the lowest in history, and no case has been reported for nine months.
Last month, I had the opportunity to visit Afghanistan, and I’m pleased that house-to-house vaccination will shortly resume for the first time in three years, bringing us closer than ever to our dream of a polio-free world.
On NCDs, in 2019, we reached agreement with 11 of the world’s biggest food companies to eliminate industrially produced trans-fats from the global food supply by 2023, and most companies say they have already achieved this goal. We have also launched a programme to certify countries that have eliminated trans fats from their national food supply.
On childhood cancer, we are now actively supporting 50 countries, providing medicines in conflict settings like Yemen and Syria, almost doubling the health workforce in some countries, supporting the construction of new cancer centres and the development of legislation to guarantee access to care for children with cancer throughout their lifetime.
On climate change, we’re supporting 14 countries, especially small island developing states, with investments at country level for climate-resilient and environmentally sustainable health facilities.
And day by day, we continue to support countries to strengthen their health systems, especially primary health care, on their journey towards universal health coverage.
This is the unglamorous but indispensable work that only WHO can do.
It has often been said that if WHO didn’t exist, it would have to be created.
A unique global mandate
With 194 Member States and 152 country offices, WHO has a unique global mandate, unique global reach and unique global legitimacy.
But over several decades, it has been progressively weakened by a debilitating imbalance between assessed contributions, which currently account for just 16% of our budget, and voluntary, earmarked contributions, which now account for 84%.
This imbalance distorts our budget and constrains our ability to deliver what our Member States expect of us. Redressing it is vital if WHO is to be the independent and authoritative global health leader the world needs it to be.
Frankly, the world doesn’t need another structure or institution;
It needs a strengthened, empowered and sustainably financed WHO at the centre of the global health architecture.
Let leave you with three specific requests:
First, we must end this pandemic, by pulling out all the stops to reach our target of vaccinating 40% of the population of every country by the end of this year.
Second, we must prevent the next pandemic, with better governance, financing, systems and tools, and by strengthening WHO.
And third, all countries must invest in primary health care as the foundation of universal health coverage.
The pandemic has demonstrated beyond doubt that health is not a luxury for the rich, or simply an outcome of development; it’s a fundamental human right, and the basis of social, economic and political stability.
There’s only one way to achieve these three things – and that’s together.
No country can end the pandemic in isolation from the rest of the world;
And no country can protect the health of its own people without working to protect the health of all people.
It takes some tough negotiations and some tough decisions. But the reward is a world that is healthier, safer and fairer for all of us.
https://interhospi.com/wp-content/uploads/sites/3/2021/10/TedrosAtWHS_web.jpg10831730panglobalhttps://interhospi.com/wp-content/uploads/sites/3/2020/06/Component-6-–-1.pngpanglobal2021-10-25 07:28:542021-10-25 07:28:54When will pandemic end? WHO Director-General provides answers at World Health Summit
French president Emmanuel Macron, and WHO Director-General Dr Tedros Adhanom Ghebreyesus, today broke ground for the WHO Academy’s campus in the French city of Lyon.
The event fulfils a commitment by the two leaders to establish a WHO Academy in Lyon’s bio-medical district to meet the needs of WHO Member States and a growing global health workforce to provide for expanded access to life-long learning, health guidance and competency-building.
Designed for collaborative learning
When it opens in 2024, the WHO Academy campus in Lyon will have high-tech and people-centred spaces designed for collaborative learning, educational research and innovation. It will also host a world-class health emergencies simulation centre that will use advanced technologies to enable health workers to sharpen their competencies amid realistic scenarios including mass casualties and disease outbreaks.
During today’s event at Lyon’s Cité Internationale, President Macron and Dr Tedros reviewed an architectural model of the building and talked via video-link with health workers who have participated in the Academy’s Mass Casualty Management programme, which is already operating in several countries including France, Greece, Afghanistan, Ethiopia and Somalia.
The quickening pace of scientific discovery and advancement of technology is making it more difficult for health workers, policy makers and other public health practitioners to keep up with evidence-based health practice and policy. As a result, it often takes more than a decade to put important life-saving guidelines into practice.
From its campus in Lyon, the Academy will offer multilingual, personalized learning programmes in digital, in-person and blended formats, deploying the latest evidence-based health guidance, state-of-the-art learning technologies and advancements in the science of adult learning.
Resilience during a health crisis
“The ambitions of the WHO Academy are not modest: to transform lifelong learning in health globally,” said Dr Tedros. “The COVID-19 pandemic is a powerful demonstration of the value of health workers, and why they need the most up-to-date information, competencies and tools to keep their communities healthy and safe.”
He added: “The WHO Academy is an investment in health, education, knowledge and technology, but ultimately it’s an investment in people, and in a healthier, safer, fairer future.”
“The quality of the health workforce is the key to resilience during a health crisis,” said President Macron. “Investing in health systems is the best way to prepare for future pandemics. Success requires unprecedented coordination of all actors. WHO is, of course, a key player and its Academy will be an essential platform for disseminating learning.”
The Academy aims to expand access to critical learning to health workers, managers, public health officials, educators, researchers, policy makers and people who provide care in their own homes and communities, as well as to WHO’s own workforce throughout the world. The vast majority will use online means to access the Academy’s programmes, which will be made available via desktop and mobile devices and in low-bandwidth settings, thereby ensuring an equitable, global and diverse cohort of learners.
Additionally, the WHO Academy will:
Harness the capabilities of new, high-impact technologies such as virtual reality, augmented reality, artificial intelligence and serious educational games to deliver health learning for maximum impact.
Formally recognize the competencies gained by learners through “digital credentials” that they can show to employers and regulatory agencies to help advance their careers.
Offer more than 100 major learning programmes by 2023, with flagship credentialed programmes for COVID-19 Vaccine Equity, Universal Health Coverage, Health Emergencies and Healthier Lives. The Academy will also offer its learners streamlined access to WHO’s full breadth of hundreds of e-learning programmes currently spread over 20 digital learning platforms as well as access to high quality learning programmes developed by others.
WHO Academy’s Executive Director
WHO also used the occasion to announce the appointment, which became effective on 16 August 2021, of Dr Agnès Buzyn as the Academy’s Executive Director. She has been serving since January as the WHO Director-General’s Envoy for Multilateral Affairs, during which time she has also supervised the Academy project.
Lead investor
As a WHO Member State and a key actor in global health, France is the lead investor in the Academy’s development, having committed more than €120 million to support its establishment and infrastructure. This achievement is possible thanks to the collective actions, commitment and financial support of the City of Lyon and the Lyon Metropole, as well as from the Auvergne-Rhône-Alpes region, which contributed €25 million of the total investment. The region will own the campus and lease it to WHO.
https://interhospi.com/wp-content/uploads/sites/3/2021/09/who_academy_Lyon_web.jpg7681417panglobalhttps://interhospi.com/wp-content/uploads/sites/3/2020/06/Component-6-–-1.pngpanglobal2021-09-27 14:42:262021-09-27 14:42:26Macron, Ghebreyesus break ground for new WHO Academy in Lyon
The US FDA has approved the first interchangeable biosimilar insulin product, indicated to improve glycaemic control in adults and paediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus.
https://interhospi.com/wp-content/uploads/sites/3/2021/09/semglee.jpg122522013wmediahttps://interhospi.com/wp-content/uploads/sites/3/2020/06/Component-6-–-1.png3wmedia2021-09-22 09:17:292021-09-22 09:17:29FDA approves first interchangeable biosimilar insulin product for treatment of diabetes
Researchers at Children’s Hospital of Philadelphia (CHOP) have developed a novel method for producing new antibiotics to combat resistant bacteria. Through an approach that would target bacteria with an antibiotic that is masked by a prodrug, which the bacteria would themselves remove, the researchers identified a method that would allow for development of new, effective […]
https://interhospi.com/wp-content/uploads/sites/3/2021/09/Audrey-Odom-John.jpg516390panglobalhttps://interhospi.com/wp-content/uploads/sites/3/2020/06/Component-6-–-1.pngpanglobal2021-09-22 09:01:442021-09-22 09:12:33Researchers establish novel approach for developing new antibiotics
Customized, biomedically applicable materials based on tropoelastin are being developed in a joint project by Skinomics from Halle, Martin Luther University Halle-Wittenberg and the Fraunhofer Institute for Microstructure of Materials and Systems IMWS. The material combines biocompatibility, durability, biodegradability and favourable mechanical properties similar to those of skin. Preclinical tests have confirmed that it is […]
https://interhospi.com/wp-content/uploads/sites/3/2021/09/fraunhoffer_tropoelastin.jpg13882080panglobalhttps://interhospi.com/wp-content/uploads/sites/3/2020/06/Component-6-–-1.pngpanglobal2021-09-22 08:54:292021-09-22 08:54:29Scientists test customized wound dressings made from tropoelastin
A form of gene therapy protects optic nerve cells and preserves vision in mouse models of glaucoma, according to research supported by NIH’s National Eye Institute. The findings suggest a way forward for developing neuroprotective therapies for glaucoma, a leading cause of visual impairment and blindness. The report was published in Cell [1].
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While body mass index (BMI) as a body composition assessment tool has long had its critics, recent research has highlighted a new potential drawback in that it could prevent people of certain ethnicities from having their risk for Type 2 diabetes assessed earlier. A psychologist and weight management specialist at Cleveland Clinic stresses the importance […]
https://interhospi.com/wp-content/uploads/sites/3/2021/09/Dr-Leslie-Heinberg-CCF.jpg23131850panglobalhttps://interhospi.com/wp-content/uploads/sites/3/2020/06/Component-6-–-1.pngpanglobal2021-09-22 08:37:532021-09-22 08:41:20Physicians urged to take note of ethnicity-specific BMI guidelines
Covid-19 vaccine inequity will have a lasting and profound impact on socio-economic recovery in low- and lower-middle income countries without urgent action to boost supply and assure equitable access for every country, including through dose sharing, according to new data released recently by the United Nations Development Programme (UNDP), the World Health Organization (WHO) and […]
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