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  2. PAAB Q&A
  3. FYI post-approval change/preclearance exemption/what requires review/PAAB scope
  4. 195 - If a company wants to make physicians aware of an optional training program by sending a letter, will the letter be reviewed by PAAB or it is content-dependamt? Any guidance on the training materials provided to physicians at the training?
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195 - If a company wants to make physicians aware of an optional training program by sending a letter, will the letter be reviewed by PAAB or it is content-dependamt? Any guidance on the training materials provided to physicians at the training?

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

    Can PAAB review it? Yes. Does the code require that the content be reviewed? The answer is partially dependent on content (both the content on the invite and the content in the "training program"). BUT, a more comprehensive way to approach this is to ask yourself "is this advertising?" I refer you to the Health Canada policy document "The Distinction Between Advertising and Other Activities". It Invites us to determine whether the advertising regulations apply by assessing the answers to the following 7 questions: What is the context in which the message is disseminated? Who are the primary and secondary audiences? Who delivers the message (the provider)? Who sponsors the message and how? What influence does a drug manufacturer have on the message content? What is the content of the message? With what frequency is the message delivered? Content is only one of the 7 factors. No one factor in itself will determine whether or not a particular message is advertising. If it is advertising and it does not meet the exemption criteria in PAAB code section 1.5, the letter should be reviewed by the PAAB. We can help you determine whether it is advertising if you submit an opinion through the eFile system (i.e. we'd need the answers to the above 7 questions).

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