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European Alliance for Personalised Medicine

EAPM: Successful IVDR meeting points the way to future collaborations

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Good afternoon, health colleagues, and welcome to the second European Alliance for Personalised Medicine (EAPM) update of the week, in which we discuss the successful In Vitro Diagnostic Regulation (IVDR) meeting conducted by EAPM yesterday (22 July), and other pressing health issues, writes EAPM Executive Director Dr. Denis Horgan. 

IVDR issues raised

Yesterday, EAPM was pleased to have conducted a successful meeting on In Vitro Diagnostic Regulation (IVDR), with more than 73 representatives from 15 countries participating as well as the European Medicines Agency (EMA) and member states’ representatives. 

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The IVDR will come into force on 26 May 2022. There are a number of areas in which there is a lack of awareness or clear guidance to support implementation at member state level. The main areas of concern relate to two issues, namely the limited capacity within Notified Bodies to grant CE marking in a timely manner, with a bottleneck occurring in the approval of some IVDs which are likely to be used for patient selection for use with precision medicines. The Commission’s Medical Device Coordination Group (MDCG) Task Force is reviewing this.

In addition, a significant proportion of predictive testing in Europe to support access to oncology precision medicines is delivered through the use of laboratory developed tests (LDTs), and there will be a new legal requirement for labs to use commercially approved tests (CE-IVD) in place of their current LDTs. If there is no CE-IVD commercial test available, public laboratories may be able to use an LDT, subject to certain provisions in the IVDR. The lab will be required to meet all the relevant requirements for safety and performance, whilst carrying out the manufacture under an appropriate quality management system.

Although health institutions are broadly aware of the IVDR, further guidance for laboratories on compliance with its key provisions would be welcomed, particularly on the exemptions to the Regulation granted under Article 5. An MDCG Task Force has very recently been established to develop such guidance, although there is little time left for laboratories to prepare for the regulation. 

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Another key issue was whether member states are expecting cost impacts as a result of the IVDR (incurred through either the switch from LDTs to CE-IVDs or the need to improve their laboratory’s quality and performance processes), and whether they have engaged with their national health authority or other relevant stakeholders on this issue. 

Finally, a key outcome of the meeting was the issue of how the regulation can facilitate some of the solutions that were proposed by member states’ representatives, and a meeting will be organized with the Commission and member states at a later date. 

On to other EU health news...

Making Europe fit for the digital age

The EU continues to lag behind China and the US when it comes to investments into key technologies such as artificial intelligence and quantum computing, the European Commission President Ursula von der Leyen has warned. “Europe is still punching well below its weight. I believe this is because of two main reasons. The first one obvious, a lack of investment,” she said. 

While European companies invest massively in research and development in sectors such as automotive or pharma, “our investment in other fields still lags behind the US and China” she added. “Artificial intelligence and quantum computing are two good examples, and due to this, far too many European startups in the tech world have had to leave the continent in order to scale up.”

Bulgaria creates patients rights’ body

Bulgaria’s council of ministers has given the go-ahead to the creation of a new directorate for patients rights under the health ministry. The new body will aid the health ministry in ensuring that patients rights are protected and work on creating programs and guidelines to improve patient protections. Generally, in Bulgaria the rights envisaged in the European legislative framework have been regulated. 

A person’s rights, including in a situation of illness (when a person is in the position of a “ patient” ) are part of the human rights regulated by the UN convention ratified in Bulgaria in 1992. 

The citizens of the Republic of Bulgaria are entitled to accessible health care and health insurance (Art. 52 ofthe Constitution, Art. 33, 35 of the Health Insurance Act (HIA)), healthy environ-ment and conditions of work, guaranteed food quality and protection against abuse of their personality. Each patient is entitled to obtain the best healthcare in conformity with the legislation. 

Cyber concerns on health 

Plans to set up an EU rapid-response cyber unit that could quickly respond to attacks like the recent ransomware hack of Ireland’s Health Service Executive (HSE) have been unveiled. Across Europe, cyberattacks rose 75% last year, with 756 such incidents logged, including an increasing number of attacks on health-care systems, representing a growing risk to society with critical infrastructure at stake, according to the European Commission. “We have a lot of cyber enemies around us,” 

European Commissioner Thierry Breton said. “Ireland’s public healthcare system suffered a pretty strong ransomware attack. I believe it affected a system with more than 80,000 computers, so that was something which was pretty, pretty strong. It could have been a very important plus, if we could have sent dedicated experts very quickly to react even faster, because we know that, of course, the longer you wait the worse it is.” 

The HSE expects it will take as long as six months to recover from the attack, with many hospital and patient data systems still affected. The cyberattack was part of a growing trend of attacks on critical systems, including on the Colonial Pipeline in the US.

Spain offers to test-run the EU's AI regulation

Spain has pitched itself to the European Commission as a laboratory to test the Artificial Intelligence Act - with more 117 AI ethics initiatives springing up around the world, initiatives to regulate artificial intelligence (AI) have sprung up around the world, spearheaded by the likes of Spain, OECD and UNESCO. It‘s time to harmonize and consolidate, a conference on AI ethics held under the auspices of Slovenia’s presidency of the EU Council heard this week. “We are clearly at a developmental point where you’ve got a lot of actors right now contributing to this movement from principles to practice, and we simply need to work together in a multistakeholder way to harmonize these approaches,” said David Leslie, of the Council of Europe’s Ad hoc Committee on Artificial Intelligence (CAHAI). 

WTO and WHO demand more vaccines

The World Trade Organization (WTO) and the World Health Organization (WHO) The World Trade Organization (WTO) have mapped critical inputs for the production of COVID-19 vaccines, in a bid to clarify complex supply chains for sourcing raw materials and components. The organizations this week published an indicative list of 83 inputs, most of which cover the manufacturing of coronavirus jabs, but also those relevant to storage, distribution and administration. It covers the vaccines produced by AstraZeneca, Janssen, Moderna and Pfizer-BioNTech, including product details and their likely HS codes when exported. The list was jointly produced with the Asian Development Bank, the OECD and the World Customs Organization, as well as representatives from the pharmaceutical industry, academia and logistics. It is subject to further modification and improvement depending on expert advice, the WTO says. The exercise was carried out amid concerns over the rate of vaccine production.

MEPs call for mutual recognition of intensivists

While Europe is getting ready to spend a second summer under the shadow of COVID-19, European decision-makers are pushing forward an ambitious agenda and preparing to deliver a more resilient and sustainable European Health Union. To make the best use of the hard-learned lessons from the pandemic, policymakers are now joining the call of the heroes of this unprecedented health crisis: the health-care workers in Intensive Care Units (intensivists) who came under enormous pressure and outdid themselves constantly to save lives. Pandemics don’t stop at our borders and Members of the European Parliament (MEPs) acknowledge the need for European solutions to a European problem. In a letter addressed to European Commission President Ursula von der Leyen, MEPs urge for intensive care medicine to be recognized as a main pillar of the new European Health Union. According to the MEPs, there is a lack of mutual recognition for intensive care medicine training among many EU countries, which prevents a fast and efficient European response in times of pandemics and other cross-border health threats.

Good news to end: EU countries double vaccine-sharing promise to 200M doses

EU countries have committed to sharing 200 million doses of coronavirus vaccines to low- and middle-income countries by the end of 2021, doubling a previous commitment.

The Commission has also pointed today to its other efforts to increase access to vaccines in Africa in particular, however the EU remains firmly opposed to a waiver of intellectual property rights for coronavirus vaccines.

That is all from EAPM for now – make sure you stay safe and well and have an excellent weekend, see you next week.

Cancer

EAPM: Headline event on the crest of a wave in fight against cancer!

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Good afternoon, health colleagues, and welcome to the European Alliance for Personalised Medicine (EAPM) update – the upcoming EAPM event is tomorrow, 17 September! It’s called ‘The need for change: Defining the health-care ecosystem to determine value’ and it will take place during the ESMO Congress, details below, writes EAPM Executive Director Denis Horgan.

Cancer screening, cancer priorities at the political level

The EAPM event comes at a propitious time for forward progress on cancer - Commission President Ursula von der Leyen has announced a new initiative to update a 17-year-old Council recommendation on cancer screening. The new 2022 initiatives were proposed in a letter of intent published during the president’s State of the Union address yesterday (15 September).  

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In addition, political party the EPP has made clear its cancer policy priorities in a 15-point programme. The policy document outlines proposed amendments to the Cancer Committee’s own initiative report. This, along with reform of the cross border health care directive — which in theory allows for patients in one member country to be treated in another — and data sharing being key to applying artificial intelligence and machine learning tools to research, and to enable the digital transformation of health care, have been issues very much at the forefront of EAPM’s recent work, to tackle disparities in cancer prevention, use of data, diagnosis, and treatment around Europe. 

The event will take place from 8h30–16h CET tomorrow; here is the link to register and here is the link to the agenda

Parliament passes two more European Health Union files

Two more European Health Union proposals will move to trilogues after passing in the Parliament’s plenary today (16 September). The proposals for the regulation on serious cross-border health threats passed with 594 votes in favor, 85 against and 16 abstentions. Meanwhile, the mandate change for the European Centre for Disease Prevention and Council (ECDC) passed with 598 votes in favor, 84 against and 13 abstentions.

The first proposal to increase the mandate of the European Medicines Agency (EMA) is already in trilogues. The second meeting will be held later this month.

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Data Governance Act

In preparation of a proposal for a new Data Act expected by December 2021, the European Commission has opened a public consultation.

The main objective of this initiative is to support data sharing within the EU economy, in particular business-to-business and business-to-government, with a horizontal scope (e.g., covering industrial data, Internet of Things, etc.). 

It aims at complementing other data-related files, such as the Data Governance Act, the GDPR and ePrivacy Regulation, Competition Law (e.g. the Horizontal Cooperation Guidelines) and the Digital Markets Act. As reported in politico, this will be tackled by deputy ambassadors in Coreper I on 1 October. An EU official familiar with the process said a few countries asked for minor changes on data intermediaries and international data transfers.

‘Risky’ artificial intelligence 

The U.N. human rights chief is calling for a moratorium on the use of artificial intelligence technology that poses a serious risk to human rights, including face-scanning systems that track people in public spaces. Michelle Bachelet, the U.N. High Commissioner for Human Rights, also said Wednesday that countries should expressly ban AI applications which don’t comply with international human rights law. Applications that should be prohibited include government “social scoring” systems that judge people based on their behavior and certain AI-based tools that categorize people into clusters such as by ethnicity or gender. 

AI-based technologies can be a force for good but they can also “have negative, even catastrophic, effects if they are used without sufficient regard to how they affect people’s human rights,” Bachelet said in a statement. 

Her comments came along with a new U.N. report that examines how countries and businesses have rushed into applying AI systems that affect people’s lives and livelihoods without setting up proper safeguards to prevent discrimination and other harms. “This is not about not having AI,” Peggy Hicks, the rights office’s director of thematic engagement, told journalists as she presented the report in Geneva. “It’s about recognizing that if AI is going to be used in these human rights — very critical — function areas, that it’s got to be done the right way. And we simply haven’t yet put in place a framework that ensures that happens.”

EU digital targets for 2030

The Commission has proposed a plan to monitor how EU countries move forward on the bloc’s digital targets for 2030. The EU will promote its human-centred digital agenda on the global stage and promote alignment or convergence with EU norms and standards. It will also ensure the security and resilience of its digital supply chains and deliver global solutions. 

These will be achieved by setting a toolbox combining regulatory cooperation, addressing capacity building and skills, investment in international co-operation and research partnerships, designing digital economy packages financed through initiatives that bring together the EU and combining EU internal investments and external co-operation instruments investing in improved connectivity with the EU’s partners. The Commission will soon launch a wide-ranging discussion and consultation process, including with citizens, on the EU vision and the digital principles.

EIB backs money for vaccines 

The European Investment Bank’s (EIB) board of directors have approved €647 million to help countries buy and distribute COVID-19 vaccines and other health projects. Vaccine distribution will benefit Argentina, as well as South Asian countries like Bangladesh, Bhutan, Sri Lanka and the Maldives. At the start of the crisis, European Investment Bank staff started working on the health emergency and the economic downturn at the same time. The Bank divided its support for biotechnology and medical companies into three main sectors: vaccines, therapies and diagnostics. The aim: to track infections, stop the spread of the disease and care for those who get sick.

Earlier this year, the Bank approved €5 billion in new financing to support urgent action in fields such as health care and medical innovation for COVID-19. Since then, more than 40 biotechnology or medical companies and projects have been approved for EIB financing worth about €1.2 billion. This put the Bank at the forefront of the fight against COVID-19.

The European Investment Bank is also backing global programmes to distribute COVID-19 vaccines, especially in the developing world. For example, the Bank recently approved a €400 million deal with COVAX, a global initiative supported by hundreds of countries, the private sector and philanthropic organisations to promote equal access to a vaccine.

Good news to finish - Coronavirus vaccines cut risk of long Covid, study finds 

Being fully vaccinated against COVID-19 not only cuts the risk of catching it, but also of an infection turning into long Covid, research led by King's College London suggests. It shows that in the minority of people who get Covid despite two jabs, the odds of developing symptoms lasting longer than four weeks are cut by 50%. This is compared with people who are not vaccinated. 

So far, 78.9% of over-16s in the UK have had two doses of a Covid vaccine. Many people who get Covid recover within four weeks but some have symptoms that continue or develop for weeks and months after the initial infection - sometimes known as long Covid. It can happen after people experience even mild coronavirus symptoms. The researchers, whose work was published in The Lancet Infectious Diseases, say it is clear that vaccinations are saving lives and preventing serious illness, but the impact of vaccines on developing long-lasting illness has been less certain.

That is all from EAPM for this week – we look forward very much to the event tomorrow, and will be reporting on it next week. Until then, stay safe, well, and here is the link to register and here is the link to the agenda

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European Alliance for Personalised Medicine

EAPM update: Beating cancer with stakeholders and data - Register now!

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Good afternoon, health colleagues, and welcome to the European Alliance for Personalised Medicine (EAPM) update of the week – as the days speed by, it is now high time to register for the upcoming EAPM event on 17 September that will take place during the ESMO Congress, details below, writes EAPM Executive Director Denis Horgan.

‘Cancer in its many forms’

As mentioned in previous updates, the conference, EAPM’s ninth annual event, is entitled ‘The need for change – and how to make it happen: Defining the health-care ecosystem to determine value’. The event will take place on Friday, 17 September from 08h30–16h00 CET; here is the link to register and here is the link to the agenda.

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This dynamics series of roundtable will look at different elements of this through the following sessions: 

  • Session I: Winning Stakeholders' Trust In Genomic Data Sharing and the use of Real World Evidence/Data
  • Session II: Bringing Molecular Diagnostics into healthcare Systems
  • Session III Regulating the future - Balance of patient safety and facilitating innovation – IVDR
  • Session IV: Saving lives through health data collection and usage

Many of the points that are highlighted below will be discussed at the conference. 

Data points way forward to beating cancer

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Parliament’s Special Committee on Beating Cancer (BECA) convened on Thursday (9 September) to focus on two key cancer care and research issues. First up on the Committee’s agenda was a discussion with the European Commission on the creation of a European Health Data Space.

The Commission’s Beating Cancer Plan envisages electronic health records playing a crucial role in cancer prevention and care and is looking to make the most of the potential of data and digitalisation, through its European Health Data Space initiative to improve cancer treatment, healthcare delivery and quality of life outcomes.

BECA Committee MEPs also held an exchange of views with the Commission on progress around the implementation of the so-called Chemicals Strategy for Innovation, which aims to deliver high levels of health and environmental protection from chemicals.

The strategy is seen as another key component of the Commission’s Beating Cancer Plan as it seeks to reduce citizen’s exposure to carcinogenic substances and other hazardous chemicals.

“The COVID pandemic has again demonstrated the fact that we are struggling to use data in order to inform the policymaking and decision-making processes,” said Ioana Maria Gligor, head of unit for European reference networks and digital health. 

The Commission is looking to fix that with a legal proposal scheduled for the beginning of 2022. 

Gligor explained that the idea is to allow health data to flow seamlessly to wherever it’s needed: between hospitals inside a country, but also between countries. 

“As of 2022, we are aiming to support access of patients to their own health data on their smart devices,” the Commission official explained. Things like genomic data can be invaluable to help diagnose rare cancers in patients, for example. And massive stores of anonymized patient data can also be used to help drive disease research using machine learning tools.

Slovenia moves EU data bill closer to the finish line

Slovenia has sharpened the restrictions for the international flows of European industrial data in a bill meant to encourage EU countries and companies to share data with each other.

Following in Portugal’s footsteps, the Slovene presidency of the EU clarified rules on the international transfer of industrial data and made small tweaks in the Data Governance Act in the fifth compromise text circulated on 7 September.

EU countries will discuss the compromise text on 14 September.

Eurobarometer results

The European Union has been working to contain the spread of the coronavirus, support national health systems, protect and save lives, as well as counter the socio-economic impact of the pandemic at both the national and EU level. Actions culminated in the Commission’s proposal for a Recovery Fund and modified multiannual budget for the EU, providing for an unprecedented level of support to help overcome the crisis.

Three out of four respondents across all countries surveyed say they have heard, seen or read about EU measures to respond to the Coronavirus pandemic; a third of respondents (33%) also know what these measures are. At the same time around half (52%) of those who know about EU action in this crisis say they are not satisfied with the measures taken so far.

Nearly seven out of ten respondents (69%) want a stronger role for the EU in fighting this crisis. In parallel, almost six out of ten respondents are dissatisfied with the solidarity shown between EU member states during the pandemic. While 74% of respondents have heard about measures or actions initiated by the EU to respond to the pandemic, only 42% of them are satisfied with these measures so far.

Around two-thirds of respondents (69%) agree that “the EU should have more competences to deal with crises such as the coronavirus pandemic”. Less than a quarter of respondents (22%) disagree with this statement.

This strong call for more EU competences and a more robustly co-ordinated EU response goes hand in hand with the dissatisfaction expressed by a majority of respondents as concerns the solidarity between EU member states in fighting the coronavirus pandemic: 57% are unhappy with the current state of solidarity, including 22% who are ‘not at all’ satisfied.

Farm to Fork Strategy

The European Parliament’s  Environment (ENVI) committees are voting on their joint own-initiative report on the Farm to Fork Strategy, which sets out how the EU aims to make the food system “fair, healthy and environmentally-friendly”. MEPs from both committees are expected to approve their joint Farm to Fork Strategy report on Friday and send it to plenary for a final vote scheduled for early October. 

And a group of lawmakers, led by the Greens’ Martin Häusling, are threatening to block the delegated act when it comes to the plenary of the European Parliament next week, arguing that the conditions it sets out are not sufficiently protective of human health. Overusing antibiotic drugs to treat farm animals will worsen the global problem of antimicrobial resistance (AMR), which has been termed the silent pandemic.

“Failure to move forward with these restrictions will be a missed opportunity. We do not have time to waste in fighting AMR,” Kyriakides said in the agriculture committee today.

The controversial delegated act is part of the revision of the EU’s animal health laws, which will start to apply from January 2022.

Good news to finish: Ministers hoping vaccines watchdog will back mass rollout of booster jabs 

UK ministers have piled pressure on the vaccines watchdog to approve a large-scale programme of Covid booster injections in time for winter, as the number of people in hospital with the virus exceeded 8,000 for the first time since March. 

On Thursday (9 September) the UK’s medicines regulator granted emergency approval for the Pfizer and AstraZeneca vaccines to be used as third shots to tackle potentially waning immunity, also putting pressure on the Joint Committee on Vaccination and Immunisation (JCVI) to approve a new jab programme. Hours later, the health secretary, Sajid Javid, said he was confident that such injections would begin imminently. “We are heading towards our booster programme,” he said. “I’m confident that our booster programme will start later this month, but I’m still awaiting the final advice.”

And that is all for this week from EAPM - don't forget, here is the link to register for EAPM's 17 September conference, and here is the link to the agenda. Until next week, stay safe and well, and have a lovely weekend!

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European Alliance for Personalised Medicine

EAPM: Paris - such a beautiful horizon to tackle cancer - Register now!

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Coming up pretty quickly, on 17 September in fact, is the prestigious ESMO Congress in Paris albeit virtually at which, for the ninth time, the Alliance will be hosting a roundtable meeting during these events, writes European Alliance for Personalised Medicine (EAPM) Executive Director, Denis Horgan. 

To perfectly match the less-than-perfect times we find ourselves in, the conference is entitled. “The need for change – and how to make it happen: Defining the healthcare ecosystem to determine value” . Registration is still open for this ‘virtual’ event, which will start at 8h30 CET until 16h CET. 

Here is the link to register and here is the link to the agenda.

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Despite us not being able to meet face-to-face, events such as this still allow the pulling together of leading experts in the arena of personalised medicine drawn from patient groups, payers, healthcare professionals plus industry, science, academic and research representatives.

A key role of a conference is to bring together experts to agree policies by consensus and take our conclusions to policy makers. And this time, we go even further into the realm of expertise, given the huge crisis that we are all facing.

It’s fair to say that, in certain quarters at least, ‘experts’ have had a hard time with it. It’s a little like critics determined to hammer a stage play, or a football pundit picking on a player - quite often it says more about the critic than the expert.

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Right now, with a pandemic on our hands, and with lives literally depending on the next moves by governments and health bosses, we absolutely need experts from all kinds of arenas and trying to ignore them, contradict them or even tear them down can, at the very least, be counter-productive and, worse, deadly.    

With this in mind, EAPM’s latest conference will bring together many core experts who will work together with the rest of our stakeholders to call attention to actions that are required now, as well as necessary as we move forward.

So, what are among the topics on the table?

The current COVID-19 crisis has thrown many European, and indeed global, healthcare issues into sharp relief.  It has also raised important questions, not necessarily new ones, but ones that have shifted more into focus during the pandemic.

One such question is whether the EU should have a bigger role in public health – and particularly in the provision of health technology. This, of course, would impinge upon the closely guarded Member State competence in healthcare so, if this were to happen, how would that be?

Another question is how can the now very evident gaps be bridged in order to better protect Europe’s health ahead of another crisis? What are the priorities? The broader question, as mentioned above, is whether it’s time to give the EU a bigger role in Europe’s health protection.

Meanwhile, at the heart of personalised medicine, is the hugely expanding use of health data. This is a sensitive topic. There’s certainly a need for the health-science community to talk more openly about using personal health data in research to enhance human health and eradicate diseases such as cancer and the public has to be at the centre of any and all discussion.

Many national and international initiatives rely on comprehensive data analytics to drive evidence-based solutions to improve health outcomes.

This means, of course, that personal health data is an extremely valuable commodity for research and should only ever be used in a responsible, ethical and secure way that is in the interest of society.  

Transparency on why and how we use data is vital if Europe is to maintain the social licence for data-driven research. Trust is paramount.

On top of this, Europe’s digital infrastructure needs strengthening in general, and in order to deal with the impact of COVID-19 in particular. And then there are future public health crises to be considered…

Better integration of Artificial Intelligence into the public health response should be a priority;  Analysis of big data relating to citizens' movement, disease transmission patterns and health monitoring could be used to aid prevention measures.

Sessions include: 

  • Session I: Winning Stakeholders' Trust In Genomic Data Sharing and the use of Real World Evidence/Data
  • Session II: Bringing Molecular Diagnostics into health-care Systems
  • Session III Regulating the future - Balance of patient safety and facilitating innovation – IVDR
  • Session IV: Saving lives through Health Data collection and usage

The above are just an example of the huge topics, among many up for discussion on the day. So be sure to join us on 17 September!

Here is the link to register and here is the link to the agenda.

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