News - Archive
BioMed Alliance sets up IVD Working Group
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The first meeting of the BioMed Alliance working group on In Vitro Diagnostics (IVD) is taking place on 12 November. This meeting will include experts from medical societies and experts from e.g. the European Commission and notified bodies. The meeting will focus on exchanging information on the new Regulation for In Vitro Diagnostics (IVDR) and on exploring how medical societies can support regulators in the implementation.
Interactions with the European Commission on the MDR implementation showed that there is an urgent need to set up a BioMed Alliance IVDR working group. The new regulation will significantly affect the evaluation and approval processes of in vitro diagnostics and medical professional input is essential for effective implementation. The first meeting will focus on the requirements of the IVDR and will define the future objectives and activities of the working group.
For more information, contact:
ECCO joins the BioMed Alliance as a new member
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The European CanCer Organisation (ECCO) has joined the BioMed Alliance as a new member bringing our membership to a total of 32 societies. We are happy that the ECCO Board and new CEO have made the decision to participate in our growing alliance and we are looking forward to working with them again on a number of common projects.
ECCO is a not-for-profit federation focussed on oncology that advocates for the right of all European cancer patients to high-quality treatment and care, promoting interaction between all organisations involved in cancer at European level. It is a multidisciplinary organisation that has 27 Member Societies representing over 150 000 professionals.
BioMed Alliance joins scientific community initiative calling for inclusion ‘research’ in new job title Commissioner Gabriel
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The BioMed Alliance has joined thousands of academics, European organisations and Nobel-prize winners in signing an open letter calling on the Commission to revise the new job title of Commissioner Mariya Gabriel to include a reference to research. The Board of Directors fully supports the initiative to request changing her official title to ‘Commissioner for Education, Research, Innovation and Youth’ as they consider that this better reflects the broad portfolio of the Commissioner.
The BioMed Alliance believes that research is vital to European wellbeing and prosperity and that its importance should be recognised by continuing including the word research in the job title of the Commissioner that is responsible for this policy area.
More information about this initiative is available here: http://www.futureofresearch.eu
European Commission recruits experts for evaluation medical devices
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The European Commission has opened a call for experts to be appointed as members of the expert panels for medical devices as described in the Medical Device Regulation.
The call is open until 10 November 2019 for all eligible applicants with expertise related to medical devices.
By participating, experts will contribute to ensuring the safety of medical devices. They will review the clinical evidence submitted for approval of high-risk medical devices and provide advice to e.g. the European Commission, Notified Bodies and Manufacturers.
Facts & Figures
- Deadline: 10 November 2019
- Application form: https://ec.europa.eu/eusurvey/runner/mdexperts2019
- Experts will contribute to the evaluation of medical devices and in vitro diagnostics
- 246 experts needed
- 1000 additional experts needed for a general list
- 10 Panels for different thematic areas in medical devices, one panel for IVDs and a screening panel will be established
- Sub-groups may be created
- Time commitment: max 2-3 days per month, mostly remote work
- Remuneration: €450 per day worked
Role:
The selected experts will need to provide consistent scientific, technical and clinical advice concerning high risk medical devices and certain in-vitro diagnostics.
Eligibility:
In order to apply, experts must hold a EU, EFTA or Turkish citizenship, possess a relevant university degree at graduate level, have at least 10 years of relevant professional experience, have a good command of the English language and they may not have a financial interest or other interest in the medical device industry. Secondly, applications will be evaluated on the basis of a set of additional selection criteria.
More information:
Find the dedicated BioMed Alliance briefing here
European Commission information:
- More information on the regulatory framework for medical devices: https://ec.europa.eu/growth/sectors/medical-devices_en
- Information on the application: https://ec.europa.eu/growth/content/call-expression-interest-expert-panels-medical-devices-and-vitro-diagnostic-medical-devices_en
- Full call text (p93): https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:C:2019:323:FULL&from=EN
Update September 2019
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Find our latest ‘Update’ here for an overview of the latest news on the BioMed Alliance in September.
Open letter to the Members of the European Parliament on sustaining EU progress in fighting against antimicrobial resistance (AMR)
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The BioMed Alliance has joined an informal group of 16 other organisations active in human and animal health and signed an open letter to the Members of the European Parliament on antimicrobial resistance (AMR). AMR is an emerging worldwide threat to both human and animal health. The letter urges Members of Parliament to bring antimicrobial resistance to the forefront of EU interinstitutional discussions and to support the establishment of a dedicated AMR parliamentary group.
EU Health Coalition Statement: establish balanced Horizon Europe that fosters research & innovation
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The EU health coalition published a new statement calling for a balanced Horizon Europe that fosters both research and innovation and supports cross-fertilisation and collaboration across the framework programme’s pillars and clusters. As leader of the Coalition’s research and innovation group, the BioMed Alliance played an important role in drafting the statement.
In light of the open consultation on Horizon Europe’s Strategic Plan, the BioMed Alliance and its partners call for a balanced approach which ensures cross-fertilisation and coordination across all relevant disciplines. This is particularly important in health research as this can benefit from efforts in multiple clusters and programmes.
Update August 2019
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Our August Update is available now, take a look here to see what the BioMed Alliance has been up to.
Update July 2019
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Take a look at our brand-new update to read about our activities in July and other related developments at EU level.
ERA-EDTA joins the BioMed Alliance
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The latest organisation to join the BioMed Alliance is the European Renal Association – European Dialysis and Transplant Association (ERA-EDTA). This new addition brings the total number of members to 31. We look forward to working with ERA-EDTA to continue promoting heath research and to improve health-related policy at EU level.
ERA-EDTA is specialised in nephrology and represents more than 7.000 physicians. It is active in Europe and the Mediterranean and it aims to promote fundamental clinical advances in the field of nephrology, dialysis, renal transplantation, hypertension and related subjects.
Medical societies urge Member States to support EU-level HTA
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Today, as the incoming Finnish EU Presidency prepares to take up the HTA legislative dossier, the Biomedical Alliance in Europe (BioMed Alliance) commends the dedication of previous EU Presidencies and it calls on the Council of the European Union to support the legislative proposal so that there can be a robust and effective framework for collaborative EU-level HTA.
Update June 2019
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Read the BioMed Alliance Update for an overview of our activities and other relevant news in June.
The BioMed Alliance together with the EU Health Coalition partners call upon the European Council to increase the total Horizon Europe budget to € 120 billion
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Ahead of the European Council Meeting (20-21 June), the BioMed Alliance calls upon Member States to adopt a Multiannual Financial Framework as well as a Horizon Europe budget which echo Europe’s ambition for innovation in research
Press Release: Providing Evidence for Regulators - Workshop on Medical Device Registries
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On 17 June, the BioMed Alliance, ESC and EFORT released a press release announcing that they are holding a joint workshop on Medical Device Registries.
Open Joint Letter with EPF and ESC: Urgent investment needed to ensure EU Medical Devices Regulation should is implemented on time
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The Biomedical Alliance in Europe has releases an open letter to EU Health Ministers with the European Patients Forum (EPF) and the European Society of Cardiology (ESC) calling for urgent investment to ensure that the EU Medical Devices Regulation (MDR) is implemented on time.
Update May 2019
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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.