Can an employee of a member company distribute a QR code that is linked to a recent Real world Evidence poster presented at a medical conference? The QR code links to an update to the published 1 year data. The data is on label and consistent with the PM. This would be considered an advertising […]
If our company is displaying at a conference are we allowed to have unbranded tools that have information on the disease state while at the same time having branded information available (Ie dose cards etc) for delegates? When you link branded and unbranded, everything becomes branded. Having both a branded tool and an unbranded tool […]
We are exploring the use of a 5 year extension study in branded APS that is not included in the sponsor’s TMA. This is an extension of the original study included in the sponsor’s TMA. If the only methodological discrepancy from the initial pivotal trial is that the primary endpoint of PFS in the extended […]
In a virtual delegate bag, provided to HCP’s at conferences are we able to include an invitation to a sponsored symposium or talk? Where am I able to find the criteria for delegate bag inserts? There are no “specific” criteria for delegate bag inserts. When creating a delegate bag insert, one should consider: What is […]
How much time does MAH have to update the existing PAAB approved APS that are still effective after a new version of Product Monograph has received NOC. Please see Q&A 377, 485 and Update of APS per new boxed warning in PM.
Can a Pharma company give t-shirts with product logo on it to their employees for their personal use? This would not fall under the scope of PAAB.
Were there any complaints in 2021? Yes. Please see the 2021 complaint report.
Can a skincare clinic advertise promotion, such as Botox/ laser promotion, providing off-label treatment, claiming 100% effective as well as encouraging immune IV drip to the customers? No. Please see the following Health Canada issued Q&A.
Hello, if at a booth for an in person conference, we are only sharing materials that have already been (individually) PAAB approved. Is a new PAAB submission required for the booth ? Yes. Please see Myth 1 and 7 for further clarification.
As references are not typical in patient information materials, do patient website submissions to PAAB require referencing? For review purposes, PAAB requires the copy deck to have references in order to validate the copy. The published website does not require references.
Is it acceptable to put a Sales Representative image as part of a VAE signature? So at the bottom of the PAAB approved email. The PAAB logo is presented on pieces that are approved by PAAB. Any alteration to that piece, renders the display of the PAAB logo invalid. It should be submitted for re-review […]
This question relates to PAAB code 3.2.3 (information on ongoing trials) Q1: Can you please confirm the elements that can be included in an APS – Study design, objectives, endpoints? Q2: We are assuming that when the code states ‘ongoing’ it means prior to an NOC which includes a trial that is no longer recruiting […]
A primary endpoint is stratified by multiple parameters, as stated in the TMA. Would it therefore be acceptable to include the subgroup analysis results for these parameters in advertising (Forest plot) from the published study, assuming they are statistically and directionally consistent with the overall primary endpoint result? There are many considerations in the assessment […]
Hi, I wanted to confirm whether an unbranded disease awareness website that does not speak about treatment would need to be a gated site? The website would be targeted to HCPs and we would have campaign emails and digital banners linking to the website. Would this website also be considered PAAB exempt because it doesn’t […]