If you have any questions about the postsubmission meeting process, please email us at: firstname.lastname@example.org.
There is a possibility that the meeting will be cancelled if unannounced individuals attend. All participants must attend in person. Only in the case of force majeure will a person be authorized to participate via teleconferencing, and this must be pre-approved.
All additional documentation requested by INESSS at the meeting must reach us no later than 4:30 p.m. on the fifth business day following the meeting. Documents received after this deadline could delay the evaluation of the submission.
The blood system product (BSP) evaluation procedure includes the opportunity for manufacturers and INESSS to hold a postsubmission meeting. This opportunity applies to requests for the evaluation or reevaluation of a new BSP or of a new indication for an already-registered BSP.
In the interest of efficiency, when a presubmission meeting on the same topic has already taken place, i.e., involving the same BSP and the same indication, a postsubmission meeting is not considered relevant unless there are exceptional circumstances involved. The specific goals of the postsubmission meeting are to:
- Provide manufacturers an opportunity to present the main elements of the evaluation request submitted to INESSS, including information about the severity of the disease, the health need, the principal clinical studies, and pharmacoeconomic and budgetary impact analyses.
- Allow INESSS to become familiar with the main elements of the evaluation request and discuss with the manufacturers certain issues that may already have been identified.
A manufacturer may request a meeting if INESSS decides that a registration application is admissible. To maximize benefits, the meeting may be held in the manner described in the decision letter.
- The meeting request must be promptly emailed to: email@example.com. The manufacturer will need to justify the request when a presubmission meeting dealing with the same topic has already been held.
- INESSS will approve the meeting request and schedule a time with the manufacturer.
- At least 72 hours before the meeting, the manufacturer must email the names and titles of the attendees and the agenda to: firstname.lastname@example.org.
- Manufacturer: up to four people, including, if applicable, an outside consultant to deal with the clinical or pharmacoeconomic aspects of the submission.
- INESSS: professionals and scientific coordinators assigned to the submission.
Conduct of Meeting
- Introduction and summary of the BSP indication;
- Presentation of epidemiological and clinical data;
- Presentation of economic data (pharmacoeconomic model, budget impact)
- Discussion period
It should be noted that the reevaluation discussions must focus on the new data in the submission that addresses the reasons for INESSS’s recommendation that the addition to the List be declined.
- At the meeting, INESSS asks that invited participants declare their real, potential or apparent conflicts of interest in order to ensure the objectivity and credibility of the evaluation process. Examples of a conflict of interest include, but are not limited to, financial support by the pharmaceutical industry (research or educational grants, honoraria, gifts, remuneration), an affiliation, a personal or commercial relationship with a manufacturer or other interest groups. This step is required for purposes of transparency.
- Six printed copies of the presentation and one copy of the attendees’ conflict of interest declaration, at the request of the manufacturer, are required at the meeting. A USB key containing all documents needed for the presentation will be collected at the end of the meeting.