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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
590

Hello, We plan to create a survey to gather statistics on lifestyle habits and general knowledge of the respondents on a virus in order to use the said metrics in a promotional tool, in the vaccination field. 1000 respondents is the usual number needed to produce relevant or serious statistics. The question is: As per PAAB's guidelines, is there a minimum number of respondents needed in a survey to be able to use the statistics produced by it in promotional tools. Thank you

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589

Hi there, I am currently creating a slide deck that the reps will use with their customers, and I am wondering how PAAB would like market research to be referenced? Is the project name, source, and date sufficient, or is there more information that PAAB requires? Thanks!

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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 each slide of the presentation clearly stating that all information is based on the US prescribing information • The local internal review team will review and attest to the presence of this disclaimer before the slide deck can be used at the event. Thank you in advance.

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587

Can you please tell us more regarding gated medical information websites. What would be considered an effective and PAAB compliant gate? Verify each HCP by License #? HCP number pattern (do we need to use specific pattern depending on the type of HCP eg: Nurses, Pharmacists, Physicians. and the province)? Thanks

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586

If a leading pharmaceutical company provides funds for an article on adult immunization but without having any control on the content of the article, can the disclaimer at the end of the article read "brought to you by a leading pharmaceutical company" or does it have to specifically mention the name of the company that provided the necessary funding.

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585

Hello - I understand that data exceeding the duration of the TMA is not acceptable (eg. TMA study A is 1 year in duration, new study B is 2 years in duration). However in a situation where a registration trial is designed to read out to 3 years, and the TMA only contains year 2 data, is it acceptable to include year 3 data in APS? Would this be dependent on the year 3 data being directionally consistent with the year 2 data?

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584

Can you please explain why a claim of "Guidelines recommend..." can only contain the generic drug name, vs. brand name? Would it make a difference if the Guidelines themselves link generic and brand names?

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583

A product receives an updated indication, removing some clinical use restrictions (patient type, duration, etc). Can the old and new indications be presented together in an APS? Can an APS make mention of the lifted clinical use restrictions (if they are now omitted from the TMA)? Thank you.

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582

Can NBRx data be used to make market share claims, if the same principles governing TRx data were applied? Example: Arbace is the #1 dispensed hypertensive among new patients. If so, would the NBRx data need to be directionally consistent with the TRx data (ie. if Arbace is in fact not the #1 dispensed among ALL patients)?

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581

For an efficacy claim, comparing head-to-head results of the study drug vs. the standard treatment, what support is required to justify the claim "significant"?

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Patrick Massad
Commissaire adjoint

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