News
Workshop on Medical Device Registries
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The BioMed Alliance, together with the European Society of Cardiology (ESC) and the European Federation of National Associations of Orthopaedics and Traumatology (EFORT), are organising a Joint Workshop on Medical Device Registries on 17 June in Brussels.
As the EU prepares to implement the new Medical Devices Regulation in May 2020, the workshop will aim to explore what role clinical registries may play in informing regulators’ market surveillance activities, and to identify a possible “common framework” for EU registries responding to the needs of regulators, patients, physicians and industry alike.
The event will bring together key experts in data collection, review and management, including European Commission officials, healthcare professionals, regulators and industry representatives.
For more information, please find the programme here.
Spring meeting approaches
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The BioMed Alliance organises its annual Spring Meeting on 14 May bringing together a diverse group of representatives from member societies. Delegates will meet in Brussels to discuss the European Elections, Plan S and Open Access Publishing and internal BioMed Alliance affairs.
During the morning session, high-level representatives from Wellcome trust and the European Commission will engage in a discussion on Plan S with publication experts from our member organisations. This is a topic of great interest as it potentially changes the publication landscape and has significant consequences for both researchers and academic societies.
The speaker list includes:
Keynote speaker: Robert Kiley, Head of Open Science at Wellcome Trust
- Panellists:
- Jean-Claude Burgelman, Head of Unit Open data Policies and Science Cloud, European Commission
- Prof. Laszlo Fesus, Chair of the FEBS Publications Committee
- Jan Cools, editor-in-chief of the HemaSphere journal, EHA
- Thomas F. Lüscher, editor in Chief of the European Heart Journal / Valentina Tursini, Scientific Publications Director, ESC
We look forward to fruitful discussions. The full programme and more information can be found here.
Medical societies unite for high quality CME
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Medical societies from different disciplines cooperate within the Biomedical Alliance in Europe (BioMed Alliance) to work towards becoming a strong common voice for high-quality Continuing Medical Education (CME) in Europe. Medical societies play a key role in the provision of high-quality education to medical professionals e.g. in the form of congresses, e-learning modules, guidelines, journals and other scientific publications.
The BioMed Alliance taskforce on the future of CME has produced an article raising awareness on the importance of unbiased and qualitative medical education. The article was written by a number of leading academics and is published ahead of print by the American Journal of Medicine on PubMed. The aim of the article is to reflect on the role of industry in CME Provision and to identify the balance that is ultimately right for patients.
A CME Experts Standing Committee was also recently established to allow for continued discussions and cooperation on medical education. The Committee held its first formal meeting on 17 April and consists of experts in medical education from BioMed Alliance medical societies. The CME Experts Committee aims to foster cooperation between medical societies and explores potential actions to guarantee excellence of educational activities. It will work together with different stakeholders to set standards on how scientific societies plan and deliver educational programmes to achieve high quality medical education for the benefit of its members with an ultimate focus on better patient care.
BioMed Alliance expresses concerns on GDPR implementation in new statement
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The Biomedical Alliance in Europe produced a statement outlining the practical consequences of the General Data Protection Regulation (GDPR) on health research. While the overarching purpose of the regulation is commendable, in practice researchers experience that its implementation hinders health research.
Bold vision needed to translate basic health research in to new ways of delivering healthcare and new treatments for patients
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Scientific communities from industry and academia through the Biomedical Alliance in Europe (BioMed Alliance) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) have teamed up to address the gaps within the translational research ecosystem and call for more focus and funding for translational research and pan European mechanisms for coordination and implementation.
ESICM becomes the 30th member of the BioMed Alliance
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We are glad to welcome the European Society of Intensive Care Medicine (ESICM) to the Biomedical Alliance in Europe, bringing the total amount of members to 30. ESICM unites more than 9000 professionals in intensive care medicine and we are sure that the organisation will provide valuable input and expertise in our activities.
ESICM was established in 1982 and the organisation supports and promotes the advancement of knowledge in intensive care medicine through education, research and professional development.
The number of specialties and the diversity in our membership continue to increase allowing us to work intensively on even more projects.
Better Education Better Care
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BioMed Alliance Members have produced a cartoon highlighting the importance of high-quality and unbiased continuing medical education for medical professionals.
Medical professionals participate in continuing education to keep their knowledge up to date and to be able to provide the best standard of care to their patients. This education is provided by independent medical associations that rely on networks of experts. It is vital that they are able to continue this important mission and that education for doctors remains impartial and based on the most relevant and reliable scientific information.
European medical experts unite to improve scientific scrutiny of evidence for approval of high-risk medical devices in the European Union
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Today, experts from the Biomedical Alliance in Europe (BioMed Alliance) are advising the Joint Research Centre (JRC) of the European Commission in Ispra, Italy, on the clinical evaluation of high-risk medical devices. Representatives of the healthcare professions will discuss how scientists and clinicians can help to implement the new EU Medical Devices Regulation (MDR) and the new EU In Vitro Diagnostic Medical Devices Regulation (IVDR).
The BioMed Alliance releases statement about Plan S
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BioMed Alliance welcomes the initiative proposed by Coalition S and supports the promotion of open access publishing. Nonetheless, we have certain concerns about the scope and implementation of Plan S, which aims to promote open access and ensure that scientific publications that receive funding from its members are made freely accessible immediately upon publication. BioMed Alliance has issued a statement outlining its feedback on Plan S.
Read the BioMed Alliance statement here
The BioMed Alliance welcomes EBC and EFORT as new members
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The Biomedical Alliance in Europe (the BioMed Alliance) is happy to announce that two new members have joined the ranks in January 2019. We would like to welcome the European Brain Council (EBC) and the European Federation of National Associations of Orthopaedics and Traumatology (EFORT) to the BioMed Alliance and we look forward to a fruitful cooperation. This year has already had a good start and there are many more interesting activities and events to look forward to.
The EBC aims to promote brain research to improve the quality of life of people that live with mental or neurological conditions. It is a platform that fosters interaction between societies, patient organisations, professional societies and industry partners. You can find more info here: https://www.braincouncil.eu/
EFORT promotes the exchange of scientific knowledge and experience in the field of prevention and both the conservative and surgical treatment of diseases and injuries related to the musculo-skeletal system. It brings together national orthopaedic and trauma associations from 39 countries across Europe. You can find more info here: https://www.efort.org/
We are sure that both new members will provide valuable new input to the activities of the BioMed Alliance therefore we can continue to advance biomedical innovation at European level.
It is time to go big on health research and implement a Steering Board for Health under Horizon Europe!
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The BioMed Alliance supports the European Parliament ITRE (Industry, Research, Energy) Committee proposal to establish a Steering Board for Health under Horizon Europe and to increase the research programme budget to €120 billion. We welcome the Partial General Approach, reached by the Competitiveness Council on 30 November as well.
The BioMed Alliance encourages the members of the European Parliament to reach an agreement as soon as possible and to vote on the rapporteurs’ reports on Horizon Europe, the flagship programme of research and innovation at the European Union level. Therefore, the research community calls on EU policymakers to initiate trialogue inter- institutional negotiations without delay and to establish a Steering Board for health to maximize the European potential in research and innovation.
The BioMed Alliance has provided recommendations and input to ensure that independent advice is available to regulators responsible for the new EU legislative framework for medical devices and in vitro diagnostics
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The BioMed Alliance submitted written recommendations, in response to the call for consultation on Scientific bodies under the new EU legislative framework. The new EU Medical Device Regulation 2017/745 (MDR) foresees an independent mechanism of scrutiny of conformity assessment of certain high-risk medical devices (class III and IIb) which is going to be conducted by expert panels. The expert panels will address a range of clinical areas of relevance such as:
- Provision of advice in relation to implementation of the EU Medical Device Regulation 2017/745 (MDR), and of the EU In-vitro Diagnostics Regulation 2017/746 (IVDR)
- Scrutiny of the clinical evaluation dossiers of certain high-risk medical devices
EU Health Summit 2018 - A shared vision for health
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The BioMed Alliance is teaming up with other European Organisations to hold a EU Health Summit on 29 November 2018 in Brussels. We are leading one of the 4 working groups on Research and Innovation.
The BioMed Alliance along with the partner organisations have put together recommendations for a shared vision for the future of health in Europe, calling upon the next European Commission and European Parliament to bring about necessary changes.
The working group on Research and Innovation has proposed 4 main recommendations to foster health research is Europe.
Please find the recommendations here:
The BioMed Alliance calls for the implementation of a “Steering Board for Health” under Horizon Europe for the coordination of health missions and health programs.
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A Steering Board for Health should coordinate health programmes and health missions under Horizon Europe, guide applicants and create greater visibility for European health research programmes.
The outline of such a steering board for health is presented as an amendment in the proposal for a decision of the European Parliament and of the Council on establishing the specific programme implementing Horizon Europe – the Framework Programme for Research and Innovation. The BioMed Alliance supports the introduction of the amendment 551 and calls on the members of the European Parliament involved in the Horizon Europe political negotiations to maintain the Steering Board for Health proposal in the text legislation. It is time to walk the talk and to ensure deeper and longer-term collaborative and transnational initiatives that address the current gaps in the ‘innovation cycle’ and strengthen cross-fertilisation and collaboration across all relevant disciplines.
EU Health Summit 2018 - A shared vision for health, Thursday 29 November, 9:00-16:00
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On November 29, the BioMed Alliance along with a large number of European organisations involved in health and healthcare policy will host the first ever high-level EU Health Summit to discuss the future of health at EU level. Bringing together European leaders, policy makers and health stakeholders, the summit will take a fresh look into how Europe could develop and take the lead in areas such as research and innovation, health data and digital health, healthcare organisation and financing as well as health in all policies. The aim of the Summit is to distil recommendations for the next European Commission and European Parliament to bring the necessary changes about.
If you would like to attend, please Register here and find more info euhealthsummit.eu/
Brexit: the European's Parliament role in prioritising patients, public health and the health security across Europe
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On September 27, the European health community held an event in the European Parliament to express their concern on Brexit negotiations and to point out to insufficient attention given to health sector. The speakers stressed that health sector and patients' representatives should be prioritised in the negotiations and that there are serious concerns regarding the Brexit impact on patients and public health. Please find the summary of the debate below.
Documents:
Press release (stakeholders' statements)
