Without knowing the content of the booth, we are unable to provide an opinion on the prominence and placement of disclaimers per the Distinction document. However, it is the PAAB opinion that all materials, including handouts, emanating from the conference should include the disclaimer. Linked assets that are not created for the conference should be covered by the disclaimer on the APS that contains the link. Should you have specific conference materials, PAAB offers an opinion service that may help with the disclaimer placements. Details may be found on our website.
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681 - Hi, at an international conference to be held in Canada, there will be a large presence from our parent company (US company), as well as some presence from our local affiliate (i.e. Canadian office). Our product is approved in both US and Canada. Our US counterparts have a booth graphic that has information based on the USPI (i.e indication as well as claims). These are not completely aligned. Is the booth with US information acceptable at this conference? (This booth will be shared by US and Canadian colleagues). Also, can the US promotional materials be handed out or does the information need to only align with the Canadian PM? And finally, can the USPI as well as the Canadian PM for this product be handed out at the conference? Thank you!
• Jennifer Carroll -
622 - Hi PAAB. I would like to inquire about the requirements for PAAB material review relating to a company-sponsored symposia (non CME/CHE accredited) being held at an International congress occurring in Canada. The symposia is being developed by the sponsors Global team, with both speakers internal to the organization and some external. If there is no mention of any specific licensed product during the presentations, is PAAB material review required? In another scenario, if case-studies related to a licensed product(s) (vaccine) in Canada were included in the presentation material to provide practical examples and inform the clinical discussion, would the materials require PAAB review? Thanks very much
• Jennifer Carroll -
588 - I would like to clarify the requirements for a PAAB material review in relation to a US-only promotional symposium at an international congress held in Canada. Our US colleagues would like to host a learning theatre program on a product that is approved for use in both the US and Canada. If the program is US-developed (independent of Canadian input) and presented to a US-Healthcare professionals audience only, is the material developed subject to PAAB review? A few mitigation steps would be in place: • All learning event promotional tools (such as the invitation) will state that Canadian physicians and any Canadian healthcare professionals (HCPs) will not have access to this event. • A check-in safeguard system will be set up at the entry of the event (such as checking and scanning the badges) to ensure access is only granted to US-HCPs. • A disclaimer will be included at the bottom of ...
• Jennifer Carroll -
534 - Hello! We, working on behalf of a European based pharma-company, are planning to sponsor an industry symposium at a 'World Congress' being held in Canada, in 2017. The content of the symposium will be generated by external speakers/expert clinicians. There may be some information/published data presented, relating to the sponsor's and other licensed pharmaceutical products, within the speakers' lectures, related to the wider context of the 'management and treatment' of the condition/s. Do the slides and any other related scientific content, for a symposium within a 'World Congress' setting, need to be submitted for review and approval by PAAB? The sponsoring company's products are licensed in Canada. Thank you, in advance, for your guidance; we appreciate your support.
• Jennifer Carroll -
520 - Health Canada's policy "The Distinction Between Advertising and Other Activities" states that materials emanating from a parent company presented during an International conference would not require PAAB review, provided that they are only used within the confines of the conference and are prominently identified as "not being authorized for sale in Canada". However, when a product presented in a promotional booth is approved in the US and in Canada as well, if: - all the material clearly specifies that all the information comes from the US labelling/Marketing Authorization, and - the target audience is from the US and not from Canada, even though some Canadian HCPs could be attending, will this be still considered as promotional activity in Canada and require a pre-clearance form PAAB?
• Jennifer Carroll