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Afin de soutenir la demande croissante, nous avons modifé la section Demandez au CCPP et l'avons rendu plus facile d'utilisation. Vous pouvez désormais sélectioner la catégorie qui vous interesse dans le menu déroulant et voir les questions qui ont déjà été posées et répondues. Vous pouvez également faire une recherche parmis les questions déjà soumises au CCPP depuis les débuts.

Questions et réponses les plus récentes
689

For clinical endpoints that are a composite of two or more measurements, is it permissible to show the individual measurements if they are not included in the TMA (ie. only the composite endpoint data is stated) ?

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688

Non branded APS I just read the following Ask PAAB questions and I require clarification: Are we required to send material on disease awareness to the PAAB, even if there is no product metnion? Hide Answer [-] PAAB Code section covers editorial pieces generated by a pharmaceutical company. That means the piece would not exist without the pharma company's financial involvement. The PAAB reviews editorial pieces where healthcare products are mentioned. See Code s7.8. Therefore, if you are talking about mechanism of action of how a therapeutic class works, and the piece is sponsored by a healthcare product manufacturer, I would say that would require PAAB review because it would be difficult not to allude to the sponsor's product and it would appear to promote the sale of that product indirectly. See Code s11.1 for a definition of "advertising" applicable to the PAAB code. Section 1 describes the scope of the PAAB Code. Editorial pieces about disease awareness that do not mention healthcare products directly or indirectly through class would be exempt from PAAB review. Keep in mind bundling that type of piece with product advertising would make the whole thing "advertising" subject to the regulations.

My question: I am working on a non-branded piece for a pharma company that will definitely send for PAAB approval. It will talk about the co-morbidity involved with a certain disease, and how this co-morbidity affects quality of life. There will be no product mention. I don't even know if this truly needs to go through PAAB or not. But assuming PAAB approval is required, what type of references would be considered acceptable in terms of talking about typical patient symptoms with various co-morbidities, and medical tests that are done to identify or qualify those co-morbidities. For example, if we want to use medical guidelines that are published in a medical journal to talk about the medical tests required to identify a particular co-morbidity, would that be acceptable? Any tips on what would not be considered acceptable for this type of APS so that I can steer clear from these issues right from the start?

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687

Regarding teaching tools (slides, desktop tool) used by HCPs to educate patients: Is it possible to include efficacy information in a piece to be used by HCPs with patients, recognizing it would be a clinic-based tool and not something taken away by the patient? Is there a regulation or code that prohibits HCPs from educating patients about efficacy results? Is there any resource that explains why this information is not included in part 3 of the Product Monograph?

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686

If we want to create an email invite which links to a promotional branded webinar (paab approved), do we have to submit the invite to paab (if the invitation itself has only name of product, time, date & link for registration)?

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685

Does the PAAB have criteria when it comes to determining acceptability of high-quality meta analyses, with respect to clinical claims?

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684

When two companies are co-promoting a product and using the same material approved by PAAB, are the promotional materials required to display both company names and/or logos or can the material have one company name and log and still be used by both companies?

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683

Hi Patrick I've been told that vaccines fall under different promotional guidelines than other prescription medicines. We are putting together a now available pharmacy fax for our soon to be promoted vaccine and wanted to confirm if we need PAAB approval on this or not. The communication would include the brand name, logo, indication, price, DIN and product number. It would also include corporate trademarks. Thanks

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682

If we create a survey asking about the impact of using intravenous vs. subcutaneous drugs on clinic/hospital resources (personnel, time, money) - and we don't mention the therapeutic area, disease state or a specific drug (neither brand nor non-proprietary name will be mentioned), would this survey be exempt from PAAB pre-clearance?

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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!

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680

Is the PAAB code applicable to the advertising of veterinary medicines? thanks!

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Commissaire adjoint

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