Spring Intro 2023

03/03/2023

Things to remember: You know your drug and its history better than the Regulator does!! Never assume that the Regulator knows more than you do! No statements not supported by data! – also holds true for SmPC!! No sweeping generalisations

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Avoid statements such as “in my opinion”, “it is well known” Don’t try to hide/bury “bad news” Ensure agrees with Quality and Clinical Overviews (they read these too!! And talk to the other assessors) No sales pitches! Always discuss relevance of animal findings to human Appropriateness of test species used Ensure what you write agrees with SmPC and vice versa!! Also, remember that SmPC is supposed to contain data relevant to the prescriber!

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