REGULAR SUBMISSION
SUBMISSIONS PROCESS
- Third-Party Educational Event submissions are only receivable via the online EthicalMedTech Conference Vetting System submission form no later than 75 days prior to the educational event starting date. The Compliance Officers endeavour to provide a decision within 30 days of receipt of the submission form.
The minimum information and details that need to be provided for a submission to be accepted under CVS have to document 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, with a notice that the conference will remain under a provisional status until 35 days prior to the conference starting date. If complete information on the missing criteria is not provided to the Compliance Officer by the 35th deadline day, the conference will not be assessed and a non-assessment notice will be posted on EthicalMedTech website. The consequence of the absence of assessment decision is that no EFPIA member can sponsor an event that has not received a formal decision.
If the Compliance Officer receives a Regular Submission less than 75 days before the event starting date, or if complete information on the three required criteria is not provided with the submission, the conference will not be assessed.
If complete information on any missing second step criteria is not received by the Compliance Officer at least 35 days prior to the conference starting date, the conference will not be assessed.
At each step of the processes, both submitting party and event’s oragniser will be informed via email of the status of the event.
Events for which organisers want to seek advice on the appropriateness of a geographic location or event venue can submit a Pre-Clearance. Such advice is encouraged to be sought by Third-Party Educational Event Organisers before they sign any contracts or make any financial commitments with suppliers regarding the Event. For example, a conference organiser which is considering holding an event in a particular city using a particular conference venue may, years in advance and up to 6 months before that planned date of the event, make a Pre-Clearance submission to the Compliance Officers.
CONDITIONS FOR A PRE-CLEARANCE ASSESSMENT
- Prior to introducing a Pre-Clearance submission, Third-Party Educational Event Organisers should look into the assessed criteria requirements.
- Pre-Clearance submissions will only be accepted via the EthicalMedTech online submission form.
- Pre-Clearance must be made by the Healthcare Organisations or Professional Conference Organisers who are the actual organisers 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.
PRE-CLEARANCE ASSESSMENT DECISIONS
The Compliance Officers will endeavour to render Pre-Clearance assessment decisions within 15 days of receipt of a complete online Pre-Clearance submission form.
Pre-Clearance decisions will only be published on the www.ethicalmedtech.eu calendar website with the specific approval of the event organiser. The website will contain a section in which the event organiser may indicate such authorisation. It is highly recommended that positive Pre-Clearance assessments be posted as soon as the event organiser is ready to make the event public. This will allow EFPIA members to incorporate the assessment into their decision-making process regarding the sponsorship of the event.
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 EFPIA members to fulfill grants and contracts obligations.
EXPEDITED ASSESSMENTS
EFPIA members and Third-Party Educational Event Organisers may request a waiver of the 75-day submission deadline from the MedTech Europe Compliance Panel. The Panel will grant such waivers only in exceptional circumstances based on valid reasons.