Spring Intro 2023

03/03/2023

– Anything not per the guidance should be clearly justified! • Ignore non-compliance and submit it anyway? – We cannot read your mind! • Full scientifically justified and well presented in the Dossier? • Could you use experience from previous procedures? Did regulators accept deviations? Maybe/Possibly. • Not sure would non-compliance be acceptable? – Consider Using national and/or EMA Scientific Advice • Good science should always prevail! What if guidelines were not followed?

03/03/2023

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15

Module 3 - What needs to be submitted?

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8