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    • U

      Disease State Clinical Reprint
      • uarabi90

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      Jennifer Carroll

      Hello @uarabi90

      In general, we may consider review articles for disease state claims when the reference is published, peer-reviewed and independent of influence from the manufacturer. This however, should not be extrapolated out to health product content (e.g. if the “practice defining documents” or “clinical practice for managing the patient population” directly/indirectly refers to health products; “treatment algorithms”; “treatment recommendations”, etc.). These should come from Canadian consensus guidelines (see Code section 3.2). It would not be acceptable to distribute these types of papers in the context of drug advertising. A complete consensus guideline could be distributed.

      The activity of sales rep discussion does not fall under the scope of the PAAB code. As a courtesy, we invite the client to consider the following when deciding whether to move forward:

      Although the activity does not fall under the scope of the PAAB code, it does fall in the realm of advertising and is thus subject to the provisions of the Food and Drugs Act. If the activity is deemed to be misleading, it could be found to be in contravention of the Food and Drugs Act.
    • F

      Clinical Paper
      • Frances

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      F

      @jennifer-carroll Many thanks

    • L

      Unbranded HCP banner leading to branded HCP website
      • LA_01

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      Jennifer Carroll

      Good morning @la_01

      No. You cannot link branded to unbranded in any manner. This is not limited to just the look and feel of the piece. Connecting through clicks is still a link and is not acceptable. All spaces would have to be reviewed in the context of the brand. This means, that while they may not have brand mention, the link requires the content on them to not exceed what is allowable in the context of the brand.

    • Jennifer Carroll

      502 - Is Pharma allowed to sponsor an independently-developed, physician-managed, online discussion forum? Pharma would have no involvement other than to provide funding for its development. What if the discussion forum is managed by Pharma's communication agency?
      • Jennifer Carroll

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    • Jennifer Carroll

      435 - We are developing an unbranded APS (Journal Ad). This APS would contain statistics and data pertaining to disease state. This APS would be disseminated directly to HCPs via print publications and perhaps some e-publications. The call-to-action on the APS would lead HCPs to register for an accredited e-CME on the disease state. Will PAAB require that the accredited CME be submitted for review?
      • Jennifer Carroll

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    • Jennifer Carroll

      421 - Can I pharmaceutical company support the development of an independent third-party publication covering the highlights of a conference in a therapeutic area where it does not yet have an approved product? The report and a summary slide presentation with the same content is developed by an independent faculty of medical experts, who have full control of the content, and coordinated by a third-party communication agency. The content is completely unbiased (less than 10% of the content is about trials on the company's future potential product), and there is no involvement of the company in the distribution of the content. The content is housed on a third-party independent website that is distributed by this third-party and/or to medical associations only. Does the site have to be gated? Does the content have to be PAAB-reviewed or accredited? Thank you in advance for your answer.
      • Jennifer Carroll

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    • Jennifer Carroll

      419 - Can a reprint be distributed by the Sales force where the use is within the approved indication, yet the reprint discusses endpoints that are not discussed within the Approved Product Monograph?
      • Jennifer Carroll

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    • Jennifer Carroll

      374 - Do slide presentations for industry-sponsored satellites at an international congress held in Canada require PAAB approval? Are there any circumstances in which unlicensed products can be discussed in such a forum?
      • Jennifer Carroll

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    • Jennifer Carroll

      373 - What is the guideline for a Med Info booth included within the footprint of a commercial booth at conferences?
      • Jennifer Carroll

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    • Jennifer Carroll

      365 - Are reports published from unaccredited CME events (ie. symposia) subject to PAAB approval?
      • Jennifer Carroll

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    • Jennifer Carroll

      350 - Is sponsorship of an accredited CME event considered marketing on the part of a pharmaceutical company? Can the CME provider include therapeutics that are not (as yet?) approved for use in Canada for a specific indication? The product has been approved in Europe and the USA for that same indication. There is no off-label issue. Only the scientific evidence will be presented concerning the drug.
      • Jennifer Carroll

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    • Jennifer Carroll

      349 - Removed 07/2018
      • Jennifer Carroll

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    • Jennifer Carroll

      336 - The data appearing in a product monograph is based on a pivotal trial. The same study also discusses 'off-label' endpoints. Can reps distribute the reprint of the study to support data that is in the PM?
      • Jennifer Carroll

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    • Jennifer Carroll

      211 - Since Jan 2009 Q&A, is there update further to question #84 on distribution of reprints and Health Canada/PAAB postiion?
      • Jennifer Carroll

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    • Jennifer Carroll

      175 - Dear PAAB. What jurisdiction does PAAB have over reprints and in particular reprints that may not be acceptable for promotional material but are consistent with and within indication. An example would be a review article?
      • Jennifer Carroll

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    • Jennifer Carroll

      166 - If a pharmaceutical company was to sponsor a Canadian Association's medical educational piece, would this require PAAB approval?
      • Jennifer Carroll

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    • Jennifer Carroll

      163 - Is there any issue in company representatives handing out invitations to online medical education programs that have received accreditation?
      • Jennifer Carroll

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    • Jennifer Carroll

      148 - Can you provide an opinion on the use of reprints with information containing both within indication information and information outside of indication. The example would be a review article that has both, yet the direction to the sales force would be to highlight and promote the medical issue and the information consistent with the product's use and indication.
      • Jennifer Carroll

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    • Jennifer Carroll

      135 - I am developing a web site to host presentations of specialists to family physicians. The website will be gated to only allow physicians and the presentations will be accredited by the College of Family Physicians and produced independently by the speaker. There will be space for physicians' comments as well discussion forums focussed around the the topics being presented. I will seek pharma sponsorship of the presentations and will declare the sponsorship on the pages where members access the presentations. Will the slides require PAAB approval and do you see any hurdles that I may face in this endeavour?
      • Jennifer Carroll

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    • Jennifer Carroll

      129 - Can sales representatives distribute Congress reports? The congress reports are commissioned by a pharma company to a third party ( ex medical communications company). Information is not focussed on company brands and is balanced and independently produced.Do these reports need to go to PAAB for reps to be able to distribute?
      • Jennifer Carroll

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