Read our April Update for an overview of the latest BioMed Alliance Activities. This month you will find more information about: the new BioMed Alliance’s member, the kick-off meeting of the CORE-MD project, the important messages communicated during the STOA Workshop, the TEHDAS Joint Action open call for stakeholders, our upcoming 2021 Spring Meeting, the joint call for an extended mandate of the ECDC, upcoming activities and our members’ news.

The BioMed Alliance joined the European Chronic Disease Alliance (ECDA) and 9 other European health organisations in a joint letter addressed to the Council of the European Union to call for an extended mandate of the European Centre for Disease Prevention and Control (ECDC).

The joint letter highlights the need for an integrated public health approach where the scope of the ECDC is expanded to other health issues than solely communicable diseases. Indeed, the letter emphasises the clinical links between communicable diseases and non-communicable diseases which require to take into account non-communicable diseases when considering the actions to prevent and control infectious diseases. The letter also argues that enhancing the data collection-efforts could provide important health benefits and foster health promotion.

The full Letter is available for reading here.

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The BioMed Alliance continues to grow and is excited to welcome the European Society of Radiology (ESR). The ESR joined in April and is the 36th member of the Alliance.

ESR was founded in 2005 by the merger the European Congress of Radiology and the European Association of Radiology to strengthen and unify European radiology and safeguard its general interests. The ESR’s mission is to serve the health care needs of the general public through the support of science, teaching and research and the quality of service in the field of Radiology in all European countries gathering around 122,343 affiliated members. We look forward to a fruitful collaboration.

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The BioMed Alliance and its members EFLM, EHA and ESC have just released a press release on the online workshop of the STOA Panel on the need for better EU policies for health. The organisations contribute to the workshop this afternoon, which brings together a mix of policy makers and experts from the field to discuss challenges around the new In Vitro Diagnostics Regulation and the need for more evidence-based EU health related policies. More information is available here.

The BioMed Alliance is very happy to announce the launch of the EU-funded CORE-MD project, a consortium of stakeholders working together to identify ways to enable the scientific, fair, and systematic evaluation of medical devices. Today, we held the kick-off meeting formally starting the work on the project.

For the first time, BioMed Alliance has been named as a partner in a European project including 22 partners involved in the development, evaluation, approval and certification, clinical use, and monitoring of medical devices. The consortium is led by the European Society of Cardiology (ESC) with the European Federation of National Associations of Orthopaedics and Traumatology (EFORT) and cooperates closely with the BioMed Alliance Taskforce on Regulatory Affairs and Medical Devices. The BioMed Alliance is co-leading Work-Package 4 “Networking” of CORE-MD which objective is to establish methods for networking between notified bodies and regulators with clinical and scientific experts.

The CORE-MD project will last three years and aims at translating expert knowledge into advice for regulatory guidance and building expertise and Regulatory Science in the clinical community. The first steps of the project will be to review the methods used in clinical trials for evaluating high-risk medical devices.

For more information, the press release is available here.

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Save-the-date for the workshop organised by the STOA Panel in collaboration with the BioMed Alliance, ESC, EHA and EFLM on 22 April 2021 from 14:00-16:00 CET.

The European Parliament Panel for the Future of Science and Technology (STOA) is organising a workshop in cooperation with the BioMed Alliance, the European Society of Cardiology (ESC), the European Haematology Association (EHA) and the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM). The workshop will focus on the new the In Vitro Diagnostics Regulation (IVDR) and the need for more evidence-based EU health related policies.

The meeting will be chaired by MEP Alexandra Geese, member of the STOA panel, and gather prominent experts on the questions related to medical devices and in-vitro diagnostics, health data and evidence-based health policies. Among the panellists are several members of the BioMed Alliance and key policy makers, including BioMed Alliance President Prof. Wilfried Ellmeier, Prof. Alan Fraser (Medical Devices Taskforce Chair), Prof. Elizabeth Macintyre (BoD Member and chair of the IVD WG) and several members of the IVD WG.

The goal of the workshop is to inform MEPs about the implementation of the new IVDR and its consequences for the health system. Discussions will also focus on the need for early engagement with medical experts to help to ensure that EU health-related legislation matches the situation in practice to ensure effective, evidence-based EU health initiatives that are targeted towards the unmet needs of patients and public health systems.

Registration to the workshop is open to the public and possible here until 21 April.

Read our March Update for an overview of the latest BioMed Alliance Activities. This month you will find more information about: the signature of the Memorandum of Understanding between BioMed Alliance and EIT Health, a preview of the up-coming BioMed Alliance Spring Meeting, the STOA Workshop organised by the European Parliament in collaboration with the BioMed Alliance and several members, a summary of BioMedScape Working Group first meeting kicking-off the work on the project, a new survey on patients involvement in Continuing Medical Education we implemented, an overview of the Strategic Plan and the Work Programme for Horizon Europe adopted by the Commission, upcoming activities and our members’ news.

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The BioMed Alliance is very happy to announce the signing of a Memorandum of Understanding (MoU) with EIT Health to facilitate cooperation related to education and the promotion of innovation.

EIT Health is one of the largest health innovation networks in Europe, representing all types of health stakeholders from academia to industry, and research and health care delivery to start-ups. It is part of the European Institute of Innovation Technology (a body of the European Union created in 2008 to strengthen innovation in Europe and part of Horizon 2020). With approximately 150 partners it aims at delivering innovative solutions to enhance the health of European citizens. 

The signing of this MoU represents a move towards closer collaboration between the healthcare innovation sector and medical societies across Europe and will greatly facilitate cooperation and allow us to work together on issues of common interest.

For more information, the press release is available here.

The BioMed Alliance has prepared a response to the consultation on the inception impact assessment for the new Health Emergency Response Authority (HERA) with its Board of Directors.

HERA is supposed to enhance EU resilience against cross-border health threats and was described by the Commission as the European equivalent of the US Biomedical Advanced Research and Development Authority (BARDA).

The BioMed Alliance welcomes HERA and believes it must receive the necessary support to properly fulfil its intended purposes. We argue that stakeholders should play a leading role in its implementation and HERA must be embedded in a forward-looking and research-driven environment.

The BioMed Alliance’s response to the consultation can be found here.

Read our February Update for an overview of the latest BioMed Alliance activities. This month you will find more information about: treatment optimisation and why it must be better embraced in our health system, the new proposal for the European Partnership for Health Innovation, a new workshop on health in Horizon Europe, the launch of Europe’s Beating Cancer Plan, the use of health data in the light of the GDPR, the European Patient Ombudsman Award for the Best Medical Practice, upcoming activities and members’ news

Read our first Update of 2021 here to see how we kicked off the year. This month you will find more information about two consultations launched by the European Commission on HERA and on the European Health Data Space, the UK participation in Horizon Europe, an update on BioMedScape, the date of the next BioMed Alliance General Assembly, upcoming activities and members’ news.

Early January the European Commission launched a consultation on the inception impact assessment for the new regulation for the European Health Data Space (EHDS) that is scheduled to be adopted during the 4th quarter of this year. The proposal seeks to address issues related to access to and exchange of health data for healthcare delivery, scientific research and innovation, policy making and regulatory activities. While the European Health Data Space aims to facilitate data exchange and enhance access to data for research and policy making, it will also increase patient access and control over their own data.

The BioMed Alliance has prepared a response to this consultation sharing its views on the inception impact assessment. You can read the response here.

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The European Commission is currently actively recruiting experts for the EXPAMED Expert panels again, which will evaluate high-risk medical devices and in vitro diagnostics. Due to several circumstances including BREXIT, there is an urgent need for additional experts; in particular in the fields of gynaecology, diabetes, orthopaedics and ophthalmology. Experts are asked to apply by 29 January 2021 on the website of the European Commission.

The BioMed Alliance raised awareness on this call in 2019 and the Commission now requests the support of medical societies to promote the call for experts again. The expert panels will play a very important role in the evaluation process of medical devices under the Medical Devices Regulation (application date: 26 May 2021), and the In Vitro Diagnostics Regulation (application date: 26 May 2022).

For more information, please find the BioMed Alliance briefing on this topic here and the application form here.

Save-the-date for an interactive webinar hosted by MEP Maria da Graca Carvalho and MEP Dolors Montserrat on 3 February 2021 from 15:00-17:00 CET.

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The EORTC and the BioMed Alliance, together with key members of the European Parliament, will organise a webinar bringing together important health stakeholders to share fresh and diverse perspectives on what can be implemented in the current EU policy programmes to advance Treatment Optimization as part of health systems.

The discussion is timely needed considering the current health challenges and the preparation of the ambitious EU Health Union programme and its policy and legislative measures such as the Pharmaceutical Strategy, the upcoming Horizon Europe, the EU4Health programme, and Europe's Beating Cancer Plan.

Recent health threats such as COVID-19 demonstrated the urgent need to have a healthcare system that places the patient at the centre and has the ultimate goal to solve clinical issues. The drug-driven approach tends to dominate treatment development in oncology and a similar tendency is seen in other medical specialities. Thus, important aspects relating to the use of novel therapies in real-world settings are neglected throughout the process such as: optimal dose, duration, sequence, combination, and quality of life. New drugs reaching the market is not an end, but a start. Treatment optimisation plays an important role in improving the way treatments are utilised in real-world conditions through the conduct of studies. These studies can provide an answer to one or multiple of the above-mentioned clinical research questions.

The agenda is available here.

You can register to the online event here and we very much look forward to welcoming you!

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