CRED SMPC 2024

17/09/2024

When information is not clear….

Peel half of the potatoes….

The Organisation for Professionals in Regulatory Affairs

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When do you start creating an SmPC?

When

FILE

PRE-CLINICAL PHASE I

PHASE II

PHASE III

PHASE IV

• Start early – in time to influence the registrational studies • But not too early – many assets drop out early in the process

The Organisation for Professionals in Regulatory Affairs

10