A letter by ERN GENTURIS member prof Marc Tischkowitz from Cambridge UK, on the detrimental effects of a no-deal Brexit to rare disease patients in the UK, was published in the Lancet.
The letter has a total of 73 signatories, 54 signatories from UK senior clinicians and researchers who are currently members of an ERN, as well as 19 signatories each representing a patient support group.
International League Against Epilepsy new virtual campus
The ILAE Academy provides a virtual campus where healthcare professionals obtain and increase essential and clinically relevant knowledge, skills, and competencies in the field of epilepsy.
Registered users can work on their competencies in epilepsy from a varied course portfolio according to different levels of proficiency. Define the learning path, track progress and earn certificates. All in one place! From the images in this post can you link directly to www.ilae-academy.org
November 18, 2020
In search of Lost Time in children and adolescents with epilepsy
Registration is compulsory and will close on December 14th: www.ptsroma.it/romaepicare2020
A 2 day workshop with 9 plenary sessions to better understand,treat and diagnose epilepsy& to develop a European strategy for epilepsy care.
It is often said that “time is brain”, an adage particularly true when facing the devastating impact early onset epileptic seizures may have. The content of this workshop focuses upon one of the priorities of the European Reference Network for Rare and Complex Epilepsies which is to: better understand and to better diagnose and treat epilepsies in children and teenagers.
All sessions bring together experts in the field and patient advocates in an effort to further define comprehensive strategies for global epilepsy care within the EU and beyond.
National networks and their role in implementing Guidelines in everyday clinical practice for the top-5 rare
& complex epilepsies (including Dravet Syndrome, Lennox-Gastaut Syndrome, CLN2, Tuberous Sclerosis,
Chairs: Nicola Specchio – Eugen Trink
A 3 years strategy for implementing EEG monitoring guidelines for neonates in the EU
Chairs: Carmen Fons – Ronit Pressler
What do we learn from surgery case-reports operated on very early in the course of the epilepsy?
Chairs: Ingmar Blumke – Tiziana Granata
Early genetic screening: when, for whom and how
Chairs: Renzo Guerrini – Gaëtan Lesca
Targeted medical therapies and clinical trials: identifying the EU priorities for the next 5 years
Chairs: Emilio Perucca – Federico Vigevano
What should be the role of the ERNs in 2030: first thoughts on the evolution of EpiCARE
Chairs: Alexis Arzimanoglou – Helen Cross
Patients building bridges with the scientific world
Chairs: Isabella Brambilla (ePAG – coordinator) – Torie Robinson (ePAG) – Nicola Specchio
Undiagnosed epilepsy patients, how to build a patient centered care pathway
Chairs: Lieven Lagae – Paolo Tinuper
Digitalized tools at the service of epilepsy care
Chairs: Paolo Curatolo – Petr Marusic
Webinar: Introduction to the ERN EpiCARE ePAG Patient Community
July 3, 2020
COVID-19 and Epilepsy – ERN EpiCARE Recommendations
COVID-19 is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). With the current global pandemic of COVID-19 the experts of EpiCARE ERN Steering Committee have prepared the following consensus statement regarding COVID-19 and epilepsy care. The document will be updated as necessary.
EpiCARE has launched a series of educational webinars with epilepsy-related topics presented by internationally renowned experts from our centres. The webinars are scheduled for the third Thursday of the month at 4 pm GMT. The online seminars are free to attend but require previous registration.
Please see the schedule for 2020 and register your interest below.
The 7th Research Meeting of the European Paediatric Neurology Society
The 7th research meeting of the European Paediatric Neurology Society will be held on the 29-30th of May 2020 in Stockholm.
The Epilepsy sessions will be chaired by Floor JANSEN (UMCU, Utrecht) and Lieven LAGAE (UZ Leuven), both members of EpiCARE.
The EPNS epilepsy working group is a very active formation of epilepsy researchers throughout Europe (with many collaborations overseas) that have collaborated in many successful projects and studies over the last years. Torbjorn Tomson is to give a keynote presentation titled “Contribution of pregnancy registries to improved pregnancy outcomes in women with epilepsy” during the meeting. Thereafter, the organisers would like to give the floor to young researchers in the field. Members of ICNA, EPNS and EPICARE ERN have been invited to prepare few slides on ongoing projects in their department or collaboration with other paediatric epilepsy centres. Young researchers are invited to submit their abstracts before February 16.
If you do not plan to present your work, we would like to encourage you to attend our working group to participate in lively discussions of new studies and ongoing projects. We look forward to receiving your contributions and to meeting you in Stockholm.
Competency-based e-learning in epileptology – testers wanted
The International League Against Epilepsy is developing interactive, online epilepsy training modules. Each training module will be based on a clinical case that a ‘doctor’ needs to treat in a virtual hospital.
EpiCARE will join this initiative and develop 10 rare epilepsy training modules.
In 2020, the ILAE Academy will launch a series of case-based eLearning modules for epileptology for Level 1 (Entry) addressing all learning objectives specified in the recently published curriculum.
In preparation for the launch, the ILAE Academy will be open for an exclusive Pilot Phase! Free access to a series of 3 newly designed self-paced e-learning courses presenting common epilepsies in a patient case scenario to successful applicants.
Participants should provide feedback however, to help erase bugs and refine the courses to user needs. Certificates can be earned upon passing a final test and completing the feedback form.
When the Academy will be fully active our teaching portfolio will include:
Self-paced (tutorless) case-based e-learning courses on the most common epilepsies – from diagnosis to treatment
Prof Ingmar Blümcke explains this program in detail below:
November 13, 2019
Frequently Asked Questions and Specific Criteria for the European Reference Networks for membership
Frequently Asked Questions
1. What is an ERN?
A network connecting health care providers and centres of expertise of highly specialised healthcare, for the purpose of improving access to diagnosis, treatment and the provision of high-quality healthcare for patients with conditions requiring a particular concentration of resources or expertise no matter where they are in Europe. For clinicians who network widely already, the ERN will represent the formalisation of their networking structures/practices in highly specialized healthcare. For those without specialist networking communities at present, ERNs will promote expertise and support health care providers in order to bring local, regional and national provision of healthcare closer to the patients.
2. What is the role of the Board of MS?
The Board of Member States (BoMS) has the responsibility of approving European Reference Networks (ERNs) and members of the Networks. The BoMS consists of representatives from across the EU Member States and European Economic Area (EEA). The Board’s main roles and responsibilities are to:
Develop and maintain rules of procedure for the BoMS (functioning and decision-making process);
Review the unfavourable opinion of the Board of the Network on the basis of the criteria and conditions set in point 2 of Annex II to Delegated Decision 2014/286/EU upon request of the Member State of establishment;
Can decide whether the application of a HCP with unfavourable opinion by the BoN can nevertheless be submitted to the Commission for further assessment;
Review the assessment reports and recommendations from the IAB;
Approve proposals for ERNs;
Approve proposals to add one or more members to an existing ERN;
Approve the termination of an ERN;
Decide on the loss of membership of one or more members of an existing ERN;
3. What are the roles of healthcare providers/CEs in ERNs?
An ERN is centred on highly specialised healthcare, first and foremost, and is expected to demonstrate:
knowledge and expertise to diagnose, follow up and manage patients with complex diseases or conditions which necessitate highly specialized healthcare
evidence of good outcomes of a multi-disciplinary approach to care
capacity to produce good practice guidelines and to implement outcome measures and
quality control o research, teaching and training
collaboration with other centers of expertise and networks
In addition, the Delegated Decision (Annex II) stipulates criteria for all ERN members to meet, with regards to:
patient empowerment and patient-centred care of organisation, management and business continuity or research and training capacity
exchange of expertise, information systems and e-health tools or expertise, good practices, quality, patient safety and evaluation
4. Are only rare diseases included in the scope of ERNs?
The scope of the ERNs, as laid out in the legal basis, is to provide highly specialised healthcare for both patients suffering from “rare diseases” or “low prevalence and complex diseases or conditions”. The Networks’ objective is to improve the access to diagnosis, treatment and the provision of high-quality healthcare to patients who have conditions requiring a particular concentration of resources or expertise.
5. How to apply to become a member of an ERN?
The applicant HCP should obtain from its Member State (MS) a written statement of endorsement certifying that its participation in the European Reference Network (ERN) is in accordance with its national legislation. The MS is responsible for defining its national process to support eligible Healthcare Providers and ensuring that this process is transparent.
The process how to become a member of an ERN is defined in the ERN Implementing Acts:
Information provided by the Networks on their websites;
Assessment manual and operational criteria;
Information how to fill out the application and self-assessment in the online tool (to be published).
6. How will applications be assessed?
The applications will have to pass four steps:
the eligibility check by the Commission,
the assessment by the Board of the Network
the assessment by the Independent Assessment Body, and
the approval by the Board of Member State.
Applicants will have to provide the endorsement of their Member State. The Assessment Manual for applicant members describes the assessment and the application process.
7. What does the conflict of interest policy cover?
Conflict of interest goes much further than only industries, academia and research institutions. It should cover each stakeholder external to an ERN that interacts with the Network at any stage and at any governance level.
According to the operational criteria for Networks (Measure 1.7.1), each ERN has to establish its own Conflict of Interest Policy, ensuring disclosure of all financial and nonfinancial conflict of interest related to the treatment or research activities before any engagement commences. Preparatory work to support all ERNs in this area is ongoing under the cross-ERN Working Group on Legal & Ethical issues & relations with Stakeholders.
The ERNs’ conflict of interest policy should respect relevant national and European legislation and follow the recommendations and guidelines developed by independent organisations and recognised bodies.
Applicants should follow the ERN rules and procedures on this issue.
8. What will be the relationship between ERN and industry?
There is no specific legal provision when it comes to the involvement of stakeholders, including industry stakeholders with the ERNs. Therefore, the Board of Member States has set up a specific working group to discuss this issue and issued a statement on the issue in 2016, prior to the approval of ERNs. An updated statement on ERNs and industry was adopted by the Board in June 2019.
The introduction of the statement reads as follow: “In recognition of the importance of the role of industry in improving the knowledge of rare conditions and developing diagnostics tools and therapies, the Board of Member States agrees with the engagement of ERNs with industry where appropriate, for example on clinical trials and research projects. However, as there is no legal provision for the collaboration between ERNs and industry, the Board of Member States offers the following guidance” (in nine specific points developed in the 2pages statement, for applicant ERN members to read).
9. Can a third country be a full member of an ERN?
No. The scope of the legal provisions of the Directive on patient rights to Cross border healthcare and all legal measures related with the ERN implementation, are only applicable to the EU and EEA member states. That implies that other third countries healthcare providers cannot participate as candidates for full membership of a European Reference Network as Affiliated Partners (Associated National Centres or Coordinating Hubs). Nevertheless, one of the criteria that Networks are asked to fulfil is to cooperate with centres and networks of expertise at international level. That would allow non-EU or EEA countries to interact and exchange knowledge or participate in research or training projects, but not to exchange any clinical data of individual patients.
10. If a centre does not meet the Criteria defined in the Delegated Act Annex II, what are the options to participate in ERNs?
For the centres that will not meet the criteria, but nonetheless could contribute to an ERN, the Member State where the centre is located, and only if not having any full member in the same Network, might take a strategic decision on the convenience to designate this center as an Affiliated Partner (Associated National Centre or Coordination Hub)
11. What are the criteria for Affiliated Partners (Associated National Centres and Coordination hubs)?
One of the roles of the Member States is to designate their Affiliated Partners (Associated National Centres and Coordination hubs).
The Board of Member States in its paper issued in January 2016 includes the position of Member States on this regard:
12. If different wards/ units/ groups belonging to the same HCP wants to join the same ERN, can they together fill in the application forms as HCP X and then specify the different diseases they work on?
Yes, if different units belong to the same HCP (hospital) they must fill in only one application according to the criteria established by the Network. In case they are applying to different Networks, they must fill in one application per Network.
13. Do we need to translate the supporting documentation for HCP proposal (Appendix B, Self-Assessment for Healthcare Providers)?
Concerning the list of documents required in the self-assessment, the HCPs are requested to provide:
for some document a full translation in English (EN)
in some case a summary in English (EN_Sum) of the documents already available in the original language.
when no specific indication is provided the documentations can be provided in the original language.
The HCP should decide based on the format and availability of information whether the summaries of supporting documentation will be provided as a separate document per measure or as one document for all measures with the same level of details at the request of the Board of the Network and/or IAB.
See table below:
14. Can a single HCP represent a multidisciplinary team or a consortium of different HCPs?
Yes. It is possible that a single HCP submits the application on behalf of a consortium (legal or functional) or a multidisciplinary team including members belonging to different HCPs (Centres or Hospitals). One of the HCPs participating shall act as legal and technical representative of the Consortium.
Different members of the consortium will not be considered as different members of the ERNs but as parts of the consortium.
The name of the consortium should be agreed by the Consortium members, and validated by the National Authority in its endorsement letter.
Typical example of a Consortium are two different hospitals that are dealing with the same diseases or conditions but addressing different and complementary age groups (adult and paediatric) or are complementing the technical or human resources for the integral diagnosis or treatment of a given groups of diseases.
However, since the Independent Assessment Body will investigate the authenticity of this agreement both in the documentation review and during on-site visits, it will be the responsibility of the HCP’s representative to provide proof of the real collaborative work among the consortium HCPs. Examples of this collaboration may include e.g. sharing resources (human or technical) and patients.
It is also very important for the HCP to explain in its application how this functional collaboration is running at the time of the submission of the application. The applicant Network Coordinator should be fully aware and acknowledge the collaborative and common multidisciplinary work of those consortia.
15. Shall each member of the consortium sign the CEO agreement form and the HCP representative form?
No. The CEO and the Representative of the main member of the consortium shall sign the CEO-Agreement form and the HCP-representative form. His/her data shall be included in the application, and he/she will take the responsibility of the application, and if approved, the participation of the consortium in the Network.
The main member of the consortium, filling in the application form, should include a brief description on the consortium in the Section: 1: ‘Consortium’:
Unit/Department/Ward name of other healthcare providers members of the consortium’ and Section 2: ‘Description of area of expertise and healthcare providers contribution to care’. Any complementary documentation related with the consortium agreement, should be kept by the main member of the consortium and provided to the Independent Assessment Body if requested.
Independent Assessment Body when assessing the authenticity of this agreement will check this information.
16. Does the new healthcare professionals located in the same hospital or consortium of an already approved ERN member need to apply to the call to participate in the network?
No. The call is for new members not for new healthcare providers or “experts”. The integration of new healthcare professionals in the member’s team shall be discussed and decided at member or network level according to the internal rules of procedure of the ERNs.
17. Does current members of the ERNs need to apply to the call to expand their area of expertise / disease coverage?
No. The procedure for approval of the new expertise/diseases coverage from already approved ERN members within one hospital shall be discussed within the Board of Member States and ERN Coordinators Group.
18. Does the signing responsible of the Applicant have to be a legal representative?
No. It shall be a Medical Doctor or a healthcare professional that is leading or representing the concrete area of expertise of the ERN interested to apply.
This person would represent the new member, if approved, in the Board of the Network.
19. Identification and logo of the ERNs members
Applicants once approved as members of a European Reference Network will be sublicensed by the ERN Coordinator in order to use the ERN logo (trademark). The logo is owned by the European Union and should constitute the visual identity of the Networks and their Members.
To download the full PDF document, please click here.
October 24, 2019
The medical team members of the European Reference Network EpiCARE, in collaboration with patient advocates, develop and deliver highly-specialized diagnostics and care to improve interventions and outcome in individuals with rare and complex epilepsies.
The ERN EpiCARE was created in 2017 and is co-funded by the European Union.
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