A IMC Member is questioning their obligation to submit slides to PAAB under the IMC Code Section 9.6 which states: "9.6 Speaker Training (Faculty Training) and Workshops 9.6.1 General Principle 9.6.1.1 For learning programs, irrespective of the format, on new products, new indications or disease state or significant label changes (i.e. patient safety), a need may arise to train an appropriate number of Health Care Professionals who are recognized experts on this information so as that they may disseminate this information to their colleagues for the benefit of Canadian patients. A product or indication is considered “new” up to one year after its initial marketing. " Assuming we are referring to a new drug or new indication. If the slides for these programs are developed by a scientific committee consisting of HCPs and the slides are then presented by HCPs to other HCPs - do these slides require PAAB approval since they make reference to a specific drug/use?
Questions about membership obligations should be directed to the association(s) you belong to. With respect to the PAAB code, healthcare product advertising directed to healthcare professionals requires PAAB preclearance. Health Canada employs the Food and Drugs Act definition of advertising and the policy document “The Distinction Between Advertising and Other Activities” to differentiate between materials that are subject to advertising and materials that are not. If you are unsure, feel free to submit a PAAB opinion such that we can fully assess the nature of the content, how it is generated (e.g. the manufacturer’s role), and all details pertaining to distribution.
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