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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
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 

621

Has the PAAB ever considered providing review comments as annotations on submission documents, rather than an itemized review letter? This would seem to save both PAAB and Clients time.

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620

I have two questions as it relates to pre-NOC submissions. (1) What constitutes a 'final draft' PM? Typically a PM is not deemed 'final draft' by Health Canada until approximately 1 week prior to actual NOC. We would like to make pre-NOC submissions earlier than this. (2) Can we submit a full HCP Detail Aid as a pre-NOC opinion request, or are opinions limited to simple reviews, such as core creative?

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619

We’re working on a new product launch and our client is looking to do a PAAB-exempt pull up banner (just product logo and legal text), however, this product has received an NOC/c approval. Are we required to put the NOC/c box on the banner, which disclaimer sea the indication statement?

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618

Hi there, We have some emails with only company information, no talks about therapeutic area, nothing about brand. We plan to send it through PTM targeting HCPs. Does this need PAAB approval? Thanks

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617

Is there any particular PAAB guidance around acceptability of a program names for patient support programs? Is the name something that requires PAAB review? Any further details you can provide would be appreciated.

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616

We're developing a branded slide deck for HCPs that will include mention of adverse events as stated in the Product Monograph. It is our intent to provide HCPs with information on how to manage adverse events (e.g. educate patients on dietary measures, consider consulting a dietitian to modify patient diet if required, etc.). Is it correct to assume that the information on how to manage adverse events within this branded APS must be supported by a textbook or recognized third-party website/materials?

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615

Hi, I have a question regarding receiving pre-clearance from PAAB regarding promotional material related to a new product that has been approved under the NOC/c (Notice of Compliance with conditions) policy, as stated in the Qualifying Notice received from HC? Is this mandatory, or optional? Thank you!

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614

Is it acceptable to advertise a statement that says something along the lines of: "Drug X is the only drug containing active ingredient Y that is approved from clinical tests?" assuming that this statement is true? Would that change if the statement is more specific, such as "Drug X is the only epidural drug containing active ingredient Y that is approved from clinical tests?"

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613

Removed 07/2018


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