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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
207
If only US data is available for a particular disease, is that acceptable by PAAB?
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206
Under what circumstances would it be acceptable to claim that two arms of a clinical trial have similar side effect profiles? Does it only relate to the type of most commonly reported adverse drug reactions in each arm or must the incidence also be comparable?
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205
The same pharma ad runs in the medical journal and the abstact meeting supplement, which are polybagged together. Can the PI run in just one or does the PI have to run in both the journal and the supplement? Or can there be only one PI -to be an outsert in the polybag?
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204

Bonjour, Article 3.5.1 du Code indique Le corps du texte doit faire référence aux résultats négatifs d'une façon nettement visible. Qu'entend-on par résultats négatifs? Comment interpréter ou comprendre cela alors que pour notre catégorie de médicament, aucun effet négatif n'apparait à la licence de mise en marché (DIN-HM). Je vous remercie par avance pour votre réponse?

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203
Hello, i am looking fro an official definition of on-label as it relates to conversations that a pharma rep can have with a HCP. Although all material need to be PAAB-approved, verbal exchange in the office can touch on latest data publicly available, such as posters, conference reports, etc. If referring to approved dosage, patient population and condition, can the reps discuss this with physicians in an effort to have robust clinical and scientific discussions... best regards
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202
We would like to reference other clinical studies from independent researchers relating to our product. Purpose is to highlight other research results & findings on different groups of patients. Research has been submitted with the PLA to support other claims used on the packaging but this research claims additional benefits. Am I able to use this research to state the results from these studies without it being in conflict of the claims made on the packaging/PLA? Please advise.
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201
Does a letter announcing provincial listing for a drug need to be PAAB'd? The letter will be a direct mailing from the pharmaceutical company to HCPs in the province announcing the listing, reimbursement criteria and indication of the product.
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200
I am a Strategic Account Manager for a Pharma Company in Toronto. My clients are Director Level and higher in Hospitals and we would like to produce a slide kit for meetings with Hospital Executives which provides information on our company (history, mission statement, values), examples of unrestricted educational grants that have been requested by organizations, information on our supply chain process and stability, PAAB approved educational & safety booklets for HCP and patients and a list of our hospital products which are approved for sale in Canada. The presentation will not include an product claims or promotional statements. Based on the PAAB Code, please confirm if this presentation is exempted from PAAB Review as it does not contain any communications in which claims, quotations and references are made for healthcare products.
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199
How do you review electronic detail aids created for tablets/iPads? Which technical features can be included in electronic details that would allow for easier detailing over a tablet/iPad? - Search keywords - highlighting sections - animations - organizing content into tabs (dosing, safety etc)
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198
Dear PAAB, We have been asked to prepare a slide presentation for our sales reps to use for group presentations to customers. These events vary in length from 20 to 60 minutes. It is not possible to create a separate slide presentation for each event. We propose a 'core' deck with the essential safety and efficacy information, and an 'enhanced' or 'expanded' deck with additional published data. Both would be PAAB-approved. In cases where there was insufficient time to present the larger presentation, the core slides would be presented and would be supplemented with a number of slides from the PAAB-approved 'expanded' presentation. Is it possible to use 2 approved slide decks in this manner? If so, how should they be submitted to PAAB for approval. Thanks for your interest.
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Commissaire adjoint  

Jennifer Carroll
Réviseur principal en communications

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