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Post-Authorisation Safety Studies (PASS)

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Overview 

A PASS may be initiated, managed or financed by a marketing authorisation holder voluntarily, or pursuant to an obligation imposed by a competent authority. A PASS can be an integral part of drug approval and continuous development. A PASS needs multi-departmental input in a company and at regulatory approval level. It is the key to applying the right methodology for the correctly identified problem.
This course offers insight into GVP Module VIII on PASS. It delivers insight into (pharmaco-)epidemiological methodology for non-interventional studies, and the concept of multi-departmental collaboration for the development and conduct of a PASS. There will be a chance to practice with real life examples.

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