Conference Vetting System

The Conference Vetting System (CVS) is a unique initiative in the healthcare industry. It is a centralised decision-making system that encourages transparency and consistency in medical education events and alleviates the complex administrative burden previously faced by MedTech Europe and Mecomed members, who were constrained to make their own determinations on whether or not a third-party educational event they wished to provide support to was compliant with the associations’ respective Codes.

NOTE: Timeframe for submissions to CVS has been reduced from 75 days to 50 days. Read More

About CVS - Mecomed

CVS is an independently managed system which reviews the compliance of Third-Party Educational Events with the Mecomed Code of Ethical Business Practice to determine the appropriateness for Member Companies to provide financial support to such events in the form of:

  • Educational Grants
  • Commercial activities (booths, advertising, satellite symposium)

CVS Mecomed is applicable to all events (International, Regional, National)

Members of Mecomed and Third-Party Intermediaries (TPIs) who represent Mecomed members, cannot provide support to an event that has not been positively assessed by CVS. Furthermore, the decisions rendered by the Compliance Officer are binding on Mecomed members and TPIs who represent them. Which means that these members cannot provide support to an event which is found to be not compliant.

The review process is based on a set of 7 criteria that each have the same weight in the evaluation:

The scientific program, geographic location, conference venue, hospitality, registration packages benefits, sponsorship packages and communication support.

Eligibility & Scope

ELIGIBILITY

Only the following categories of stakeholders may submit an event for assessment:

  • Mecomed Corporate Members & Associates
  • TPIs who represent Mecomed Member Companies
  • Medical Associations
  • Healthcare Organizations (HCOs) including Hospitals
  • Professional Conference Organizers (PCOs)

The following Third-Party Educational events are under the scope of CVS- Mecomed:

  • International
  • Regional
  • National

Exempt from the CVS – Mecomed:

1: Local in-institution activities

Local events organized by an HCO on its premises (in-institution activities) are exempt from the CVS assessment process only if all following conditions are met:

  • The event is organized on the premises of the HCO (medical facility such as clinic, hospital, laboratory etc.).
  • The event is of medical education content and is addressed to the Healthcare Professionals of the organizing HCO.
  • There are no registration fees for the participation of HCPs in the event.
  • There are no related travel or accommodation costs for the participating HCPs.
  • Any type of support provided by Member Companies or their Third-Party Intermediaries (TPIs) is provided to the HCO itself and not to individual HCPs.

2: Public Awareness Campaigns:

Event organized by HCO intended to provide information, promoting awareness and/or educating patients and the public about relevant healthcare topics or medical conditions or diseases in therapeutic areas. Such an event is exempt from CVS submission.

In case any part of the agenda includes any session addressed to HCPs, the event cannot qualify as Public Awareness Campaign.

SCOPE

CVS- Mecomed covers the region of Middle East & Africa, excluding South Africa.

Time Frame for Submissions

The submission of an application for any Third-Party Educational Events (national, regional and international) on the CVS website must be done 50 days prior to the event starting date or earlier.

Submissions made after the 50-day deadline will be attributed automatically as the final status “not assessed/late submissions”. No exceptions will be allowed.

 At this stage, the following information is needed as a minimum requirement:

  • Name of the event
  • Date of the event
  • Venue name
  • Location of the event

The submission of the complete set of documentation for an already registered/listed event in CVS is recommended to be done a minimum of 35 days prior to the event starting date.

In addition to the above-mentioned information, the following documentation is required:

  • Detailed Program with a clear time frame format
  • Communication Support (website or brochure)
  • Registration Fees for delegates
  • Sponsorship packages / Prospectus offered to companies to participate in the event

It will take between 3 to 4 weeks to do assessment for events , depending on the starting date of the event and availability of full documentation.

Pre-Clearance

OBJECTIVE

Pre-Clearance provides Third Party Educational Event Organizers the possibility to seek the advice on whether or not the minimum required criteria to initiate discussions with Mecomed members on their financial support to an event are compliant with Mecomed Code. Such advice can also be sought by Third Party Educational Event Organizers before they sign any contracts or make any financial commitments with suppliers regarding the Event.

For example, a conference organizer who is considering holding an event in a particular city using a particular conference venue may, years in advance and up to 6 months before the planned date of the event, make a Pre-Clearance submission on CVS.

CONDITIONS FOR A PRE-CLEARANCE ASSESSMENT

Prior to introducing a Pre-Clearance submission, Third-Party Educational Event Organizers should look into the assessed criteria requirements.

Pre-Clearance submissions will only be accepted via the EthicalMedTech-CVS online submission form.

Pre-Clearance must be made by the Healthcare Organizations or Professional Conference Organizers who are the actual organizers of the educational event in question.

An educational event may be submitted for Pre-Clearance years in advance but not later than six months prior to the event starting date.

The geographic location and event venue details are the minimum information required for a Pre-Clearance to be accepted under CVS.

PRE-CLEARANCE ASSESSMENT DECISIONS

The Compliance Officer will endeavor to render Pre-Clearance assessment decisions within 3 weeks of receipt of a complete online Pre-Clearance submission form.

Pre-Clearance decisions will only be published on the www.ethicalmedtech.eu calendar website.

All events, whether they have been Pre-Cleared or not, must go through the Regular Submission Process. An overall assessment of the event is still mandatory for Mecomed members to fulfill grants and contracts obligations.

Regular Submissions

REGULAR SUBMISSIONS PROCESS

Regular Submissions must be made via the online EthicalMedTech Conference Vetting System submission form on the www.ethicalmedtech.eu website.

The minimum information and details that need to be provided for a submission to be accepted under CVS are the geographic location and the conference facility venue.

In such case, the Compliance Officer will render a provisional assessment decision limited to the criteria which have been assessed at that point. The provisional decision will be posted on the www.ethicalmedtech.eu website.

REGULAR SUBMISSIONS ASSESSMENT DECISIONS

The Compliance Officer will endeavor to render Regular Submission assessment decisions upon the receipt of a complete online submission form.

In cases where a negative decision is made, the Compliance Officer will notify the identified relevant stakeholders via a correction notice regarding the identified deficiencies which render the event non-compliant and advise those stakeholders that they have 10 calendar days prior to the publication of the final assessment decision to correct those deficiencies.

All decisions will be published on the www.ethicalmedtech.eu calendar website.

Third Party Procedure Training

Background:

Chapter 2 of the Mecomed Code of Ethical Business Practice provides that Member Companies may support Third Party Organized Procedure Trainings either: via Educational Grants (in accordance with Chapter 4: Charitable Donations and Grants);

OR by providing financial support directly to individual Healthcare Professionals to cover the cost of attendance at Third Party Organized Procedure Training sessions.

Third Party Organized Procedure Training means a type of Third Party Organized Educational Event that is primarily intended to provide Healthcare Professionals with information and training on the safe and effective performance of one or more clinical procedures in circumstances where the information and training concern:

Specific therapeutic, diagnostic or rehabilitative procedures, namely clinical courses of action, methods or techniques (rather than the use of medical technologies); and practical demonstrations and/or training for HCPs, where the majority of the training program is delivered in a clinical environment.

For the avoidance of doubt, proctorship and preceptorship are not considered to constitute Third Party Organized Procedure Training.

Checklist:

Program:

Unlike Third-Party Organized Educational Conferences which are theoretical in nature, practical, hands-on activities comprise the majority of the program of Third-Party Organized Procedure Trainings (“TPPTs”).

The program must include practical demonstrations (and/or actual live surgeries where allowed).

To consider an event a TPPT, the practical sessions must in all cases represent more than 50% of the full program and involve hands-on activities by the attendees. This requirement must be clearly indicated in the program of the TPPT.

Will be considered practical sessions:

  • Hands-on sessions in which all attendees to the TPPT participate actively.
  • In these sessions attendees perform specific procedures on settings and environments appropriate for the practice of the relevant procedure.
  • Examples of hands-on may include surgery simulations where the technologies relevant to the specialty are practiced on cadavers; skin models; synthetic bones; cath labs; etc.

Venue:

Third-Party Organized Procedure Trainings are typically organized in a clinical environment, as opposed to, e.g., a classroom setting. For the avoidance of doubt, the adjective “clinical” includes places suitable for the simulation of medical procedures, rather than just the medical treatment of real patients.

Examples of simulation settings include conference or meeting rooms which are appropriately equipped with relevant simulation devices/systems or experimental laboratories suitable for training on cadavers, skin models, synthetic bones, live animals in accordance with applicable regulations and ethical rules, etc.

Stand-alone event:

Third Party Organized Procedure Training will not qualify as a Stand-Alone if the Training is organized in connection, adjacent to, or at the same time and location as part of a larger Third-Party Organized Educational Conference. In such cases, direct sponsorship to Healthcare Professional will not be permitted.

Assessment Criteria

Assessment Principles:

Each educational event submitted under the Conference Vetting System for assessment is evaluated by the Compliance Officer in accordance with the principles and standards set out in the Mecomed Code of Ethical Business Practice. Image and perception projected to the public when industry wishes to support a particular event are determinant in the assessment decisions under CVS.

Please note that:

The rendered decisions are based on the documents and information provided to the Compliance Officer via the online submission form. The Compliance Officer does not independently verify whether the information or documents are up to date.

Decisions do not take into account nor supplant national and local laws, regulations or professional and company codes that may impose more stringent requirements upon members or Healthcare Organizations or Healthcare Professionals.

Educational event scientific program sessions are reviewed, but not the value of their scientific content.

The sole purpose of the System is to assist corporate members in determining whether or not to sponsor third party educational events.

The review process is based on a set of 7 criteria of equal weight in the assessment process, as follows:

1: The scientific program

The detailed program should present a clear schedule with no gaps during the event scientific sessions, (i.e., a minimum of 6 hours for full conference day/ 3 hours for a half day), the faculty for each session must be identified, the session topics must be serious medical subjects.

The program content should directly relate to specialty and/or medical practice of the HCP who will attend the event or have a sufficiently reasonable relationship to justify the attendance of the HCPs.

2: The geographic location

The geographic location should not be the main attraction of the conference. It should be in or near a city or town which is a scientific or business center conducive to exchange of ideas and the transmission of knowledge.

The selected time of the year will be taken into account in determining if a geographic location is appropriate.

3: The event venue

The event venue should be a business or commercial center providing conference facilities conductive to the exchange of scientific and medical information and the transmission of knowledge. The image of the location among the public, media and authorities cannot be perceived as purely luxury, touristic/holiday and/or entertainment venue.

CVS does not look into the financial advantage that a venue rental may present.

4: Hospitality

Hospitality includes Accommodation, meals/breaks and receptions (opening reception, gala dinner). It is important to differentiate hospitality which is permitted and entertainment which is not.

Hospitality should be limited to reasonable hotel accommodation and meals, coffee breaks, and a conference dinner or cocktail reception to which all HCP delegates are expected to attend.

The hospitality offered to spouses, partners, family and/or guests – this category of person may not benefit from hospitality sponsored by Mecomed members.

The appropriateness of accommodation – Mecomed members funds to third party events cannot be used to pay for or reimburse HCP lodging expenses at top category, luxury or resort hotels.

5: Registration fees

The registration fee should cover only the scientific program, authorized activities and hospitality.

Spouses, partners, family and/or guests’ packages may not be paid for by Mecomed Members – This category of person may not register for the event or participate in the scientific program (unless he or she is a qualified HCP with a legitimate interest in the program).

Any social, sporting and/or leisure activities or other forms of entertainment must be outside of the program schedule and paid for separately by the HCP delegates. They should not dominate or interfere with the overall scientific content of the program and must be held during times that do not overlap with scientific session.

6: Communication support

Advertising support (brochures, website and other materials) should highlight the scientific nature of the program content. They should not emphasize the geographic location and should not make excessive or inappropriate references to or contain images of entertainment, sporting events or other non-scientific activities.

7: Sponsorship Packages:

The 7th criteria is the only difference between Mecomed & MedTech Europe CVS criteria of assessment. Mecomed Compliance Committee decided to add the 7th Criteria for assessment (Sponsorship packages) based on a legitimate need to mitigate risks arising from sponsorship packages in the Mecomed region.

Sponsorship packages should comply with Chapter 1: General Criteria for Events of the Mecomed Code.

Sponsorship packages should be transparent, clearly outlining the value of the sponsorship package options, as well as the different benefits provided under each sponsorship package.

Examples of non-permissible benefits include, but are not limited to, gifts to delegates or speakers, first class tickets, business class tickets for flights less than 5 hours, touristic tours and other entertainment options, such as participation in live music or sports events etc.

It is the responsibility of each Mecomed Member Company to ensure that any free delegate passes distributed under sponsorship packages will not be used for direct HCP Sponsorship and will be allocated via educational grants, without any involvement of the Member Company in the delegate selection process, in accordance with the requirements of the Mecomed Code.

Submit a Conference

CVS Appeals

An appeal may be filed by a Member Company or a Third-Party Educational Event Organizer to the Mecomed Compliance Officer in writing.

Any appeal must be documented and motivated with written legitimate justifications.

The Mecomed Compliance Officer will forward the appeal request to the Mecomed Compliance Core Committee as defined in Part 3, Section 4 of the Mecomed Code.

The Mecomed Compliance Core Committee will assess the appeal and the relevant documents/ justification and shall take a decision within a maximum of 10 working days from the receipt of the appeal request.

The security level of the venue in comparison to other venues, the number of expected attendees, the availability of conference facilities, the overall suitability of the selected venue, the specificity of the geographic location, logistics considerations and any other compelling justifications can establish the granting of a change to the CVS decision.

The rationale for amending the CVS assessment should be clearly documented along with the initial Event's assessment outcome on the CVS.

CVS Compliance Team

Mecomed Region CVS:

Arwa Asiri
Mecomed Compliance Officer – Middle East & Africa (except South Africa)
[email protected]

The Mecomed Compliance Officer operates under the supervision of the Mecomed Compliance Core Committee whose role is to ensure the impartiality, competence, and integrity of the decision-making process and prevent conflicts of interest.


MedTech Europe Region CVS:

Clarisse Aillet
Compliance Officer
[email protected]


Myriam Invidia
Assistant Compliance Officer
[email protected]

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Membership is open to all MD&D companies operating throughout the Middle East & Africa region.

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