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Would a live event whereby healthcare professionals are invited to hear key opinion leaders discuss unmet need in a therapeutic area and a drug that has just obtained NOC be deemed subject to preapproval by PAAB? The live events would be sponsored by the pharma company whose drug has just obtained NOC. The purpose would be to inform prescribers of the approved indications and appropriate clinical usage. The program would not be accredited.

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  This would be a promotional meeting and the meeting itself is not subject to PAAB review. However, if the pharma company sponsor provides slides to the speakers or materials to the meeting health professional attendees, they would be an Advertising/Promotional system (APS) subject to PAAB review. Prescribing information (could be a product monograph or a package insert) should be available at the meeting.