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vincent

@vincent
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The responses, guidance, and advisories provided by the Pharmaceutical Advertising Advisory Board (PAAB), including but not limited to those available through the PAAB Forum, the PAAB website, and any PAAB correspondences, are specifically intended to assist individuals navigating the PAAB preclearance system. Repurposing or reproducing this content without written consent from the PAAB Commissioner is strictly prohibited. This prohibition includes, but is not limited to, use in machine learning or AI models.
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  • Materials for an American congress in Canada
    V vincent

    Hi! An American congress for HCPs is taking place in Canada in 2024 and there will be attendees from both the US and Canada. We are developing a website and a leave-behind for this congress on behalf of an American pharmaceutical company with an investigational agent that is not currently approved for use in any country. These materials will be completely unbranded and will only discuss the disease and the current class of therapies; we would also like to discuss the burden of medication, challenges with adherence, and low/slow response rates to the class of therapies that are currently available for this disease. The website will be available after the congress, so the Canadian attendees would presumably be able to access this site once the congress is over.

    Do these materials fall under Health Canada purview? If so, would this website and leave-behind need to be submitted to PAAB?

    FYI post-approval change/preclearance exemption/what requires review/PAAB scope
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