Effective January 2013, all providers seeking accreditation of their live continuing medical education (CME) programs from the European Accreditation Council for CME (EACCME) will have to abide by new requirements set by its parent organization, the European Union of Medical Specialists (UEMS) at its October meeting in Cyprus. ?The new criteria parallel those of the US accreditation system and the recommendations of the Good CME Practice Group, an initiative of the European CME Forum.?
The European Union of Medical Specialists (UEMS) was founded in 1958 with the aim of representing the interests of specialist doctors at an international level. The UEMS is a non-governmental voluntary organization comprising the national medical organizations that represent medical specialists in the European Union and in associated countries. With a current membership of 34 countries, and 39 specialist sections, the UEMS provides for the representation of approximately 1.4 million medical specialists working in Europe.?
In announcing the new criteria for live educational events (LEE), Edwin Borman, MB ChB, secretary general of the UEMS, said: ?The requirements for Europe are being strengthened, and now move providers to do more, e.g., appropriate needs assessment, targeted educational objectives and some measure of outcomes, as well as full financial disclosure.? ?Here are some key clauses:??
- The provider must structure the LEE to fulfill defined educational needs for a defined target audience
- The provider must identify and communicate expected educational impact in a doctor?s practice, and provide for feedback on the extent to which objectives were met
- The LEE must include methods to promote active learning, including opportunities for audience participation
- The provider must ensure that all faculty and members of the Scientific and/or Organizing Committee disclose potential or actual conflicts of interest and that actual conflicts have been resolved
- The source of all funding for the LEE must be declared and available to learners;
- Content must be free of any sponsor influence and of any form of advertising or bias?
The Accreditation of Live Educational Events by the EACCME??
The UEMS established the European Accreditation Council for Continuing Medical Education (EACCME?), in January 2000, with the aim of encouraging high standards in the development, delivery and harmonization of continuing medical education (CME). This was to be achieved through the international accreditation of CME events, and the establishment of a system for the international acceptance of CME credit points. After just over a decade of function, the UEMS-EACCME? (henceforth EACCME?) accredits around 1400 applications per year for meetings providing international CME. In 2009, the EACCME? introduced a system that provides for the accreditation of e-learning materials.??
In its policy paper, from 2001, the Basel Declaration on Continuing Professional Development (CPD), the UEMS defined CPD as ?the educative means of updating, developing and enhancing how doctors apply the knowledge, skills and attitudes required in their working lives?. The UEMS remains committed to this concept that encompasses educating medical specialists for the wider responsibilities required for specialist medical practice.??
The UEMS acknowledged the need for CME credits as a simple means of confirming involvement in CME/CPD, hence has introduced a common ?CME currency?: the European CME Credit (ECMEC). While the EACCME? provides a credit-based accreditation system, the UEMS draws attention to its policy, stated in the Basel declaration, that doctors should employ a range of educational methods and not rely solely on formally accredited CME for their continuing education. ?The UEMS has agreements based on the mutual recognition of credit points with the American Medical Association ? for live educational events and for e-learning materials ? and with the Royal College of Physicians and Surgeons of Canada ? for live educational events only.
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Accordingly, the EACCME? described the criteria and mechanisms for its accreditation of Live Educational Events (LEEs). ?This accreditation will apply for all European countries and specialities that have a recognition agreement with the EACCME?, and for countries providing CME/CPD events that will be attended by doctors who reside in Europe. The paper states what criteria will be applied for the accreditation of LEEs, and describes how the Provider of CME/ CPD (henceforth referred to as ?Provider? ? see appendix 6) should apply for EACCME? accreditation.
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The UEMS defines live educational events as meetings, the primary purpose of which is the provision of educational material of a medical nature to doctors, with the aim that they will achieve educational benefit. It is expected that, as a result of this educational process, patients also will benefit from the lessons, applied in practice, that their specialist doctors have learned. ?The UEMS recognises that some educational activities employ a range of methodologies, hence straddle areas of definition. The EACCME? will consider the accreditation of such activities on the basis of: the primary form of presentation; or the potential for the learner to engage, actively, with the educational event or material.
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The UEMS draws attention to differences in national recognition arrangements for CME/CPD credits obtained from attending LEEs, and emphasises that doctors must refer to these when providing a record of their CME/CPD activities. ?The newly published document represents the updated criteria that will be applied by the EACCME? when considering applications for the accreditation of LEEs, as of 1st January 2013. This document supersedes all previous documents related to such accreditation, originally UEMS D9908 and subsequent revisions. ?This document will apply until reviewed, in no later than three years? time.
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Educational Objectives and Fulfillment of Learning Needs
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The Provider must structure the LEE to fulfill defined educational needs. ?The application must demonstrate that a ?needs assessment? process has been completed, how that process was performed, and what relevant educational needs have been identified from that process.
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The Provider must define the ?target audience? for whom the LEE is most likely to be suitable. ?This must be explained in terms of the specialties and seniority of doctor(s) most likely to benefit (henceforth referred to as the ?Learner(s)?).
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The Provider must identify and communicate the expected educational outcome(s) of the LEE. ?These must be explained in terms of the expected educational impact in knowledge, skills, attitudes or behaviors, or ethical lessons, and where in a doctor?s practice this will have an impact.
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Description of the Live Educational Event
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The Provider must provide the title of the LEE, its venue, date(s), and a clear description of the nature of the event. ?This must indicate whether the LEE will involve lectures, discussions, workshops and/or other educational methods, single or multiple sessions, and whether these will be sequential or in parallel. ?The EACCME? will consider applications for whole meetings, or, where these fulfill minimum time-based criteria, for specific components of a meeting. Separate applications for accreditation will be required for academic satellite symposia that are not part of the conference program.
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The LEE must be presented in a manner suitable for an international audience. ?The LEE will need to demonstrate that it can accommodate the educational needs of an international audience with the primary language determined by the composition of the audience and facilities available for interpretation as required. International terminology for procedures and therapeutic agents must be used.
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The LEE must include methods to promote active learning. ?The application should state how this will be achieved. Examples include: multimedia presentations; protected time for question and answer sessions; opportunities for audience participation; key-pad votes and discussion.
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The Provider must provide detailed information on the duration of the LEE. ?This is particularly important in order that the EACCME? can determine the maximum number of ECMECs that may be claimed by a Learner who has attended the LEE. This must be a minimum of one educational hour, with each hour of educational time expected to count as one ECMEC, up to a maximum of 3 ECMECs for a half day and 6 ECMECs for a full day. The educational time can be structured flexibly throughout the day.
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The Provider must indicate the mechanism(s) by which it will be verified that the Learner has engaged with the LEE in order to fulfill the educational objective(s). ?As a minimum this must involve a mechanism for confirmation of attendance at the LEE. ?The UEMS encourages the use of more sophisticated methods, such as smart cards confirming attendance at specific sessions, requiring the Learner(s) to complete questions based on the LEE material, requiring the Learner(s) to complete feedback forms, etc. ?An online evaluation system linked with the provision of a CME certificate also will be acceptable.
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The LEE must be conducted in compliance with all relevant ethical, medico-legal, regulatory, industry-based and legal requirements. ?For example, this should include: confirmation of confidentiality for patients and other participants, or consent to inclusion of non-identifiable details within LEE presentations, compliance with research ethics requirements, compliance with data-protection legislation, and copyright arrangements. It is essential to ensure that patients are not, and cannot be identified in any of the materials presented. The relevant legal, regulatory and industry-based standards will be those for the country in which the LEE is being held.
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Details of the Provider
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The Provider must provide a short description of the Provider organization(s). ?The Provider must submit a short description of their own organization, and any other(s) with which they are working with regard to this specific LEE, specifying, in each case, the organization?s contribution to the LEE. Where the Provider is a CME company producing a program on behalf of another organization (e.g. pharmaceutical or device manufacturer) their relationship must be fully disclosed.
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The Provider must state the names and job titles of the individual(s) responsible for preparing the LEE. ?The name and contact address of the person/organization primarily responsible for the delivery of the LEE must be provided. In addition, if these are from different organizations, the names and contact addresses must be provided of the persons/organizations responsible for the planning of the LEE, the administration of the LEE, the scientific program content of the LEE, and for billing purposes.
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The Provider must provide the name, title and contact details of a medical practitioner who will take responsibility for the application for accreditation of the LEE. This doctor must be registered with a Medical Regulatory Authority, and his/her registration details must be provided. ?Normally this will be a senior member of the Organizing Committee for the LEE. In all circumstances, this doctor will be expected by the UEMS to have verified the information submitted on behalf of the Provider in the application for accreditation.
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The Scientific and/or Organizing Committee
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The Provider must provide the name(s), job title(s) and contact details of the head, and all other members of the Scientific and/or Organizing Committee. ?The person responsible for, or in charge of the committee responsible for, the planning of the scientific content of the LEE must be clearly identified.
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The Provider must ensure that all members of the Scientific and/or Organizing Committee provide written declarations of potential or actual conflicts of interest. ?All declarations of potential or actual conflicts of interest, whether due to a financial or other relationship, must be provided to the EACCME? upon submission of the application. Declarations also must be made readily available, either in printed form, with the program of the LEE, or on the website of the organizer of the LEE. Declarations must include whether any fee, honorarium or arrangement for re-imbursement of expenses in relation to the LEE has been provided.
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The Provider must confirm that any actual conflicts of interest have been resolved .
Where there has been an actual conflict of interest involving a member of the Scientific and/or Organizing Committee, the EACCME? must be informed of how this has been resolved. The EACCME? considers it a responsibility of the head of the Scientific and/or Organizing Committee to ensure that actual conflicts of interest are addressed.
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The Scientific and/or Organizing Committee must ensure that the LEE will provide a program that presents a scientifically balanced perspective of the subjects included.
This must include impartiality in the scheduling of subjects, lecturers and opportunity for discussion. Challenge through peer-review by participants during discussion sessions within the LEE can provide an effective safeguard.
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The Faculty
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The Provider must ensure that all members of the Faculty provide written declarations of potential or actual conflicts of interest. ?These declarations must be made publicly available, either in printed form, with the program of the LEE, or, in electronic form, on the website of the organizer of the LEE. The EACCME? considers it a responsibility of the head of the Scientific and/or Organizing Committee to ensure that actual conflicts of interest are resolved. The EACCME? has provided a template, available on the EACCME? website, that provides a guide as to what information must be declared. These declarations must be retained for at least one year after the event for potential review by the EACCME?.
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The Program
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The Provider must provide the latest version of the program of the LEE at the time of application. ?The information provided must include the required details of Faculty members and the titles of lectures, etc. that they will be delivering, and the expected learning outcomes. Details regarding the duration of individual lectures, workshops and sessions must be included, making clear the planned number of educational hours per day. The EACCME? will not permit major changes to the program following confirmation of accreditation. ?Following the LEE, the Provider must also send the final version of the program to the EACCME? highlighting any differences from the version submitted with the original application for accreditation. ?
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Funding of the LEE
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The EACCME? will only consider for accreditation LEEs that fulfill specific requirements related to their funding. Accordingly, events provided by the pharmaceutical and medical equipment industries will not be considered for accreditation.
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The source(s) of all funding for the LEE must be declared, and be made available to Learners in a readily accessible manner. ?Failure by a Provider to disclose the means of funding of a LEE will lead to rejection of its application. The Provider must provide documentation confirming the basis of the funding for the LEE, whether this is by sponsorship, educational grant, or any other means. While all sources of funding must be declared, the actual amounts provided need not be.
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The Scientific and/or Organizing Committee must confirm that it has determined the content of all aspects of the LEE to be free of any attempt by sponsors to influence the Committee?s decisions. ?All funding must be provided free of any attempt to influence the program, individual sessions, subjects for discussion, content or choice of Faculty members.
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The Provider must submit information regarding the expected total number of Learners attending the LEE and the schedule of fees for these Learners. ?The EACCME? recognises that, prior to the LEE, only provisional figures can be provided. The final figures must be included in the feedback report of the event that must be submitted to the EACCME? following completion of the LEE. Grossly or significantly inaccurate attendance declarations will lead to automatic rejection of an application and/or future applications.???????????????????????????????????
Promotional material??
All educational material must be free of any form of advertising and any form of bias.?
The EACCME? will reject any application that, in its opinion, includes advertising of any product or company directly related to any educational material. ?The EACCME defines ?bias? as ?a tendency or preference towards a particular perspective, ideology or result, especially when the tendency interferes with the ability to be impartial, unprejudiced or objective.? ??Bias may be scientific, political, economic and financial, religious, gender-related, ethnic, racial, cultural or geographical. ?Bias may occur in relation to a particular industry or commercial product such as a mechanical device or pharmaceutical agent, or in relation to a particular intellectual, political or other view, in situations where a range of products or views may be equally useful or valid.??
Specific examples that will lead to automatic rejection of an application include: the use of a sponsor?s name in the title of the scientific program, a scientific session or a scientific lecture; the display of brand names and/or individual company logos in scientific lectures or in the scientific program. The EACCME? will accept a single page acknowledgement, in the scientific program, where all sponsors are recognized for their support of the LEE and programs that include the names of satellite symposia only if they are clearly identified as industry sponsored. All advertising components (including the listing of exhibitors) must be clearly separated and distinguished from the scientific/educational components of the program and identified as such.??
Where there is a valid evidence base for a specific therapy or agent, this may be stated, but this must be referenced in a manner that is appropriate for a scientific journal.??
The Provider must confirm that it will comply with the applicable national rules, regulations and industry standards regarding exhibition areas where companies are permitted to present their products.??
Review by Learners??
The Provider must provide a reliable and effective means for the Learners to provide feedback on the LEE, including the extent to which the educational objectives of the LEE were met. The Provider must commit to make available to the EACCME? a report on this feedback and on the Provider?s responses to this.??
These reports, and the responses to them by the Provider, will inform the EACCME? of the Provider?s track record for future applications for accreditation. The EACCME? will make available, as examples of good practice, suitable feedback forms.??
The EACCME? reserves the right to request doctors, who will be attending the LEE, to provide independent reports on the fulfillment of the criteria set out in this policy.?
The EACCME? will reject any application that, in its opinion, includes advertising of any product or company directly related to any educational material.??
Application?
The EACCME describes in this document the process for how CME providers can apply to have their program accredited.
Special Thanks to Lew Miller at Wentz-Miller for alerting us of these new requirements.
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