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Materials for an American congress in Canada

Scheduled Pinned Locked Moved FYI post-approval change/preclearance exemption/what requires review/PAAB scope
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  • V Offline
    V Offline
    vincent
    wrote on last edited by
    #1

    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?

    Jennifer CarrollJ 1 Reply Last reply
    0
    • 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?

      Jennifer CarrollJ Offline
      Jennifer CarrollJ Offline
      Jennifer Carroll
      wrote on last edited by
      #2

      Happy Friday @vincent

      The nature of this question is complex and there is more information that would be required to answer it. We would suggest submitting an opinion where all the details required to make the assessment can be provided.

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