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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Preclearance is most effective as a regulatory mechanism when promotional tools are used in the precise way in which they were reviewed. In your provided example, the expanded presentation could indeed be reviewed as a potential add-on to the core presentation. However, the review (and approval) would presume that the complete expanded deck would be presented.Additionally, the slides in the expanded deck should be presented in the same order that they were reviewed. If further personalization is required to account for variability in time constraints, you may wish to separate the expanded slide set into several smaller packs of slides. Each pack would be reviewed as separate submission files but with the understanding that they will always be presented after the core slide set (such that standard fair balance elements need not be duplicated in each slide set). Because each expanded pack will be reviewed as distinct files, PAAB can ensure that any element used in the expanded segments will be accompanied by the required copy-specific balance, quantification and/or qualification. Note that any presented expansion pack must be presented from beginning to end with all slides used in the same order in which they were approved. The client will be free to include as many or as few of the expansion packs as time permits. Each expansion pack should be separate and distinct sections of the presented slide set. For example, this could be attained by employing a cover slide identifying the key topic(s) for each expansion slide (e.g. "Dosing").
