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Questions mises à jour jusqu’au: 4 octobre 2021

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804

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 with a placeholder for the reps image. Please reach out to PAAB with the specifics of the eFile in order to determine next steps.

803

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 but collecting data.

Q1: Yes, study design, objectives and endpoints, can be presented in a non-promotional manner per code section 3.2.3. Remember that the study must still be in the data gathering stage, with no interim analyses having been performed (including safety analysis), and it must be disclaimed accordingly.

Q2: Please see Q&A 537 and Q&A 223.

802

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 of subgroup analysis for claims in advertising. See PAAB Guidance on Subgroup Analysis for more comprehensive guidance.

801

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 mention treatment?

If the website is disease state only and there is no direct/indirect mention of treatment, it may qualify as exempt. The promotion of the website would also need to have no mention of treatment. Mentioning treatment in a linked tool would be linking advertising to non-advertising (the exempt piece) and render it all advertising and subject to review. Note that there should be no branding elements such as colours or images that would link it to advertising. If the site is targeted to HCPs but there is no gate, DTC regulations would apply as well as HCP regulations. We would suggest this piece be reviewed for use in both audiences.

One additional caution. A disease state piece or campaign which focuses on a pathway or therapeutic area for which no products currently exists or the sponsor has a product coming for, may be perceived as pre-NOC advertising. See Pre-NOC Corporate/Editorial Communications.

800

Product name on sales business cards

If the product name appears with a message which identifies a therapeutic area, it would prompt the inclusion of the indication and lowest level fair balance. If there are no claims or copy on the business card which would suggest therapeutic use, it would likely be acceptable. Question 280 and 413 further elaborate. If you are uncertain, you may submit for an opinion to confirm the piece is exempt. .

799

Hello, I've had a launch announcement PDF file approved for e-mail distribution by PAAB. If I want to send this exact same file via fax, do I need to get it approved again by PAAB? Thanks.

If the unaltered PDF is being delivered via fax, this does not require re-review but should be submitted as an FYI for assessment. See also Q&A 650.

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