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Demandez au CCPP

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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
631

We have a Enrollment Form for a PSP program that has been previously approved by PAAB. We have a PDF writeable format which we would like our PSP Field Case Managers ( Nurses) to send to our HCPs via email. Could you please provide any limitations or requirements to this, if any?

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630

We have a question regarding controlled distribution/gating of a website containing information intended for HCPs. We understand that options for creating an acceptable barrier include "URL of a website which is not indexed" (as presented during Jennifer Carroll's talk "From Email to Virtual Reality" during PAAB's 2017 National Workshop). However, we are unable to find any further information from PAAB or from Health Canada regarding what "not indexed" means in this context. Can you please elaborate, or point us to guidance documentation outlining what "not indexed" means for a site's URL, in order to create an acceptable barrier for the site?

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629

Hi there, Can the wording "NOW APPROVED IN CANADA" be PAAB exempt for a 2nd indication? Thanks

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628

Hi, we have a new product in our pipeline that is currently undergoing an approval process with Health Canada and is targeting a specific biomarker. We would like to do a campaign to HCPs regarding this specific biomarker and to raise the physician's awareness of this biomarker as an emerging target for a particular disease. Is such campaign acceptable, considering that no mechanism of action nor information on the pipeline will be discussed?

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627

We would like to make non-clinical comparisons between products that are specifically indicated for different subtypes of a disease state (eg. phenotypes of COPD). Would this be acceptable, given the common umbrella disease state?

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626

We have an ongoing pivotal study and would like to report the latest published data. While the data exceeds the duration of that mentioned in the TMA, it is directionally-consistent with respect to magnitude/significance, and no additional safety concerns were identified. Can we report this data in APS, if there is no emphasis placed on the duration?

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625

For a piece containing TMA dosage forms and dosing instructions, but no therapeutic/pharmacological claims, would low-level balance be sufficient?

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624

For an HCP targeted APS, are references required in the final layout of the piece after PAAB approval (i.e., a reference list at the end of the piece and superscripts throughout)? Or do references not need to be included in the layout once PAAB has approved the copy doc? Thanks!

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623

Hi; I have a questions regarding usage of the trade mark of the competitor in the promo materials. The owning promo material company wants to include the registered information from the competitor's PM. would it be acceptable to use the competitor's registered trademark in the piece? Thank you

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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 

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Patrick Massad
Commissaire adjoint

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