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64 - Does exhibit booth panel text generated by head offices outside of Canada require PAAB approval for International conferences and symposia held in Canada? Does an entry in an Exhibit Guide for an International conference or symposium generated by head offices outside of Canada summarizing a recent peer reviewed published clinical trial require PAAB approval?
• Jennifer Carroll -
60 - Can you please provide some clarity on the criteria regarding co-sponsorship with a physician/patient/nurse/pharmacist group(s) that would allow for PAAB exemption? That is, what criteria make one group more or less acceptable from a PAAB perspective? To clarify, if a pharma company wishes to sponsor the development of and work with an organization to supply patients with information on a particular disease state/condition in an unbranded piece how does PAAB judge whether this would/would not be exempt from pre-clearance.
• Jennifer Carroll -
47 - If we offer samples to physicians, by a 3rd party company, do we need to get PAAB approval of the offer/promotion if it only contains an graphic/image of the brand name, logo, and quantity of samples offered. There will be no claims made...only this minimal information. Does a PI need to accompany the offer?
• Jennifer Carroll -
43 - I am interested in producing an empty folder with my product name and logo on the front, PI on the back. The folder is to be provided to representatives with no contents. Reps would have a choice of any currently valid and PAAB approved contents to place inside, the whole package to be left with the physician. When I submit the folder to the PAAB for review, is it sufficient to explain that the only possible contents will be valid and PAAB approved APS, or is it necessary that I submit with all the possible combinations and permutations of contents? Am I permitted to submit for review a reprint which I would also like to be available for inclusion?
• Jennifer Carroll -
1 - If a fax were to be sent to physicians stating only the study name (I.e. ABC), what disease area it was studying (i.e. CHD mortality) and the major results (i.e. decreased mortality) but there was no drug mention; but provided a website for the study and a 1-800 number for further information, would this require approval? What if name of the study included both drugs that were compared (i.e. Alefacept Benzoperoxide Comparison)?
• Jennifer Carroll