Requirements for the accreditation of a CME/CPD activity)
All the criteria below are ESSENTIAL criteria.
THE PROVIDER MUST:
- Structure the LEE to fulfil defined educational needs.
A needs assessment must be carried out prior to the development of a CME/CPD activity. The process of a needs assessment is designed to identify the gap between a current situation and a desired situation.
There are different types of needs assessment:
- Evaluation results from a previous activity
- Surveys of potential participants
- Publication of a new clinical guideline or new research
- Legislative/regulatory/organizational changes affecting patient care…
The discrepancy between the current situation and desired situation must be measured to appropriately identify the need. The need can be a desire to improve current performance or to correct a deficiency.
A short description of this needs assessment process and derived educational needs must be provided.
- Define the “target audience” for whom the LEE is most likely to be suitable.
The target audience must fall within the remit of the ECPhA (fully qualified medical specialists). The target audience must therefore be explained in terms of specialty and seniority of the learner.
An ECPhA® accredited event is open to all interested medical and other healthcare professionals, not only those fitting the described target audience.
ECPhA® certificates can therefore be distributed to any other healthcare professional attending the accredited event (i.e. nurses, pharmacists, clinical scientists …) who wishes to benefit from ECPhA® credits. It is expected that the healthcare professional’s association will recognise the ECPhA® credits on a voluntary basis. - Identify and communicate the expected educational outcome(s) of the LEE.
An expected educational outcome is a formal statement of what participants are expected to learn in an event. Expected learning outcome statements refer to specific knowledge, practical skills, areas of professional development, attitudes, higher-order thinking skills, etc. that faculty members expect participants to learn, develop or master after attending the event.
When defining an event’s learning outcomes, action verbs must be used to express what participants will be able to do. Eg. analyse, create, compare, evaluate.
Example: “After attending the event, participants will be able to + action verb + something.”
A list of educational outcomes must be provided.
- Provide the title of the LEE, its venue, date(s), and a clear description of the nature of the event.
Title: must be identical with the title used in all materials related to the event. It is not permissible to have an industrial sponsor’s or a commercial product’s name in the title of the event.
Venue: The ECPhA® deals with the accreditation of international events in Europe and outside of Europe (with the exception of the USA and Canada with which the ECPhA® has agreements of mutual recognition of credits).
For international events in Europe the ECPhA® will seek to have the approval from the National Accreditation Authority of the country where the event takes place.
For international events outside of Europe the ECPhA® accepts to consider such applications if European participants and/or faculty attend the event.
However, the ECPhA® encourages the accreditation of international events outside of Europe even though there are no European participants and no European faculty. In this case ECPhA® accreditation is considered as a “mark of excellence”. For those events the ECPhA® will apply the standard ECPhA® criteria. These events should attract participants from several countries. The application and programme must be submitted in English.
Date: the ECPhA® will accept one set of dates per event. A separate application must be submitted for each repetition of the same event.
Nature of the event: You will need to state whether the event is a:
- Congress
- Conference
- Course
- Satellite symposium
- Hands-on workshop
- Other: applicant needs to clarify…
The ECPhA® will NOT consider for accreditation commercial symposia.
THE LEE MUST:
- Be presented in a manner suitable for an international audience.
The ECPhA® will not consider for accreditation purely local/national events with only local/national participants attending. This is the remit of a National Accreditation Authority.
However, a national event attracting foreign participants may be considered for accreditation by the ECPhA®.
The ECPhA® accredits international events in the whole world (except for the USA and Canada) with European participants/faculty attending and without European participants/faculty attending as long as the event attracts participants from several countries and the programme submitted with the application is available in English.
International terminology for procedures and therapeutic agents must be used. - Include methods to promote active learning.
The ECPhA® encourages the use of methods promoting adult active learning.
The methods used can be one or a combination of the following:
- Discussion time
- Quiz
- Q&A session
- Training session
- Groups
- Open space
- Electronic communication
- Other: applicant needs to clarify. - Be conducted in compliance with all relevant ethical, medico-legal, regulatory, industry-based and legal requirements.
THE PROVIDER MUST:
- Provide detailed information on the duration of the LEE.
The provider will need to state the starting time and ending time for each day of the programme (including lunch breaks and coffee breaks), together with the number of educational hours per day and for the whole event.
Only purely scientific sessions will be considered for accreditation.
Therefore, commercial sessions, coffee/lunch breaks, opening/closing ceremonies, assessments etc. will not be awarded ECPEC®s.
- Indicate the mechanism(s) by which it will be verified that the learner has engaged with the LEE in order to fulfil the educational objective(s).
Simple registration of attendance at the event is not sufficient.
You will need to explain how the participants’ attendance is monitored during the event and to include in the learner’s feedback form questions related to the relevance of the content and speakers.
- Provide a short description of the Provider organisation(s).
The Provider must submit a short description of its own organisation, and any other(s) with which they are working with regard to the LEE. Where the Provider is a CME company producing a programme on behalf of or supported by another organisation (e.g. pharmaceutical or device manufacturer) their relationship must be fully disclosed and any financial sponsorship must be under the form of an unrestricted educational grant.
- State the name and job title of the individual responsible for preparing the LEE.
This person cannot be a doctor/professor/member of staff working for the industrial sponsor or educational company of the LEE.
- Provide the name, title and contact details of a senior medical specialist 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.
This person must be a doctor and his/her registration number (with a Medical Regulatory Authority) must be provided. By Medical Regulatory Authority we mean the authority that delivers to doctors the right to practice medicine. The medical practitioner who will take responsibility for the application is the person who will complete and sign the director’s declaration to be provided at the time of the application.
- Provide the name(s), job title(s) and contact details of the head, and all other members of the Organising and/or Scientific Committee.
See template “Organising/Scientific Committee” to be completed and provided at the time of the application.
No member of the industrial sponsor’s (of the LEE) staff is allowed to be on the Scientific/Organising Committee.
- Ensure that all members of the Organising and/or Scientific Committee provide written declarations of potential or actual conflicts of interest.
Each member of the Scientific/Organising Committee must state its financial interests for the last three years. The COI forms must be dated and signed. The COI forms of the members of the Scientific/Organising Committee must be provided at the time of the application.
The COI forms of the members of the Organising/Scientific Committee must be made available online on the event website and in the printed scientific programme.
Providers who have been granted the status of “Trusted Provider” do not need to supply the COI forms at the time of submission of the application but the forms have to be completed before the LEE takes place and have to be available for an on-site control by the ECPhA®. - Confirm that any actual conflicts of interest have been resolved.
This criterion is applicable to members of the Organising/Scientific Committee and is the personal responsibility of the scientific head of the faculty (including chairmen, moderators, presenters…).
The provider must ensure that any actual conflict of interest has been resolved. This can be done in several ways:
- Every faculty member must provide a declaration of COI as a second slide of his/her presentation.
- The evaluation form completed by participants must include a question on the faculty’s bias.
- The COI form of all members of the Organising/ Scientific Committee and faculty must be made available in the printed scientific programme and on the event website.
- Member of the Organising/ Scientific committee or faculty is excluded from the preparation of the scientific programme.
- Ensure that all members of the Faculty provide written declarations of potential or actual conflicts of interest.
All members of the faculty must provide written declarations of COI. These declarations must not be submitted at the time of the application but must be made available in case of on-site control by the ECPhA®. - Provide the latest version of the programme of the LEE at the time of application.
The programme must contain as a minimum:
- details of faculty members
- titles of lectures, etc.
- start and end time of individual lectures, workshops and sessions
- overall expected learning outcomes
It is not permissible for a member from the industry to be on the scientific programme.
The ECPhA® will not permit major changes to the programme following confirmation of accreditation. Major changes will require a new application to be submitted.
Following the LEE, the Provider will send the final version of the programme to the ECPhA®, highlighting any differences from the version submitted with the original application for accreditation. - The source(s) of all funding for the LEE must be declared, and be made available to Learners in a readily accessible manner.
The source of all funding must be declared.
Funding can occur via:
- provider’s own funds
- participants’ registration fees
- unrestricted educational grant from sponsor
- exhibition booths during the event
- commercial symposia organised during the event (not eligible for ECPEC®s)
- advertisements outside the scientific programme
- provision of a range of tools during the event
- if other: please specify
Sponsorship (from one or more sponsors) of an event can only be considered as long as the grant is in the form of an “unrestricted educational grant” and all other ECPhA® LEE criteria are met.
The ECPhA® reserves the right to ask for the contractual arrangement between the provider and the sponsor.
THE ORGANISING AND/OR SCIENTIFIC COMMITTEE MUST:
- Ensure that the LEE will provide a programme that presents a scientifically balanced perspective of the subjects included.
This must include impartiality in the scheduling of subjects, lecturers and opportunity for discussion.
- 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 programme, individual sessions, subjects for discussion, content or choice of faculty members.
In the case the sponsor is a pharmaceutical or medical device industry, the sponsor cannot be directly involved in the provision of the event. The sponsor therefore cannot:
- Invite participants and speakers
- Cover travel/accommodation costs of participants and speakers
- Take part in the organisation of the event (invitation of participants, registration of participants, staffing, catering, speaker’s fees…)
- Take part in the development of the scientific programme (no funding company member on Organising/ Scientific Committee, no influence on the choice of the speakers/selection of topics…)
- Be on the scientific programme (no speaker from the industry will be allowed on the scientific programme…)…
- All educational material must be free of any form of advertising and any form of bias.
The ECPhA® will reject any application that, in its opinion, includes advertising of any product or company directly related to any educational material.
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 programme, a scientific session or a scientific lecture;
- the display of brand names and/or individual company logos in scientific lectures or in the scientific programme.
The ECPhA® will accept a single page acknowledgement, at the end of the scientific programme, where all sponsors are recognised for their support of the LEE. The details of industry satellite symposia (title, speakers, sessions, sponsors…) may only be published in a separate section after the scientific programme.
All advertising components (including the listing of exhibitors) must be clearly separated and distinguished from the scientific/educational components of the programme and identified as such.
The event website cannot be hosted on the industry sponsor’s website and cannot bear the industry sponsor’s logo (except under a separate tab “sponsor” where the sponsor will be acknowledged).
Full instructions on the acknowledgement of sponsors and sponsored symposia in the event material are available in chapter XVI.
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. Only generic names will be permitted.
THE PROVIDER MUST:
- Submit information regarding the expected total number of participants attending the LEE and the schedule of registration fees for these Learners.
Expected total number of participants:
This number includes all participants in the event whether they are specialist doctors or not. It also includes speakers and exhibitors/sponsors participating in the event.
The applicant will have no right to reduce the expected number of participants after submission of the application.
Registration fee:
A LEE may be provided free of charge but only if all participants are admitted without fee (supported for example from an unrestricted grant or subsidised by a scientific society…) and there is no sponsorship from industry.
- 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 ECPhA® a report on this feedback and on the provider’s responses to this.
Providers are encouraged to ensure that a feedback form is completed by the participants at the end of the event. The feedback form must include questions on the lecturer, presentation, content, value of each session and possible bias.
The Applicant will provide the blank Feedback Questionnaire that will be distributed to participants at the event.
Participants will only be able to receive their certificate of attendance once they have completed the feedback form. They can only receive the number of ECPEC®s corresponding to their actual attendance.
Based on the participants’ individual feedback, the provider must submit a feedback report (better known as “event report”) to the ECPhA® within four weeks of the completion of the event. This report must include the participants’ feedback, information on the total number of participants and any perception of bias by participants. Failure to provide feedback could jeopardise recognition of any future applications.
Appendix 1: participant’s evaluation form
Appendix 2: provider’s feedback report - 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.
The provider has a duty to check if special arrangements regarding accreditation and recognition of CME credits apply in the country/region where LEE takes place. The ECPhA® strives to monitor local regulations but it is not always notified of local changes in a timely manner and the provider has responsibility to make sure that participants, particularly local participants, will have their CME credits recognised.
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