From Product Characterization to Clinical Reliable Specifications

Presented by

André Mischo, Associate Director Science & Technology at Novartis

About this talk

Defining product ranges needs to consider to assure product quality / efficacy and patient safety. One further element is that wide product ranges are beneficial for defining a longer shelf life or granting more in-use times or allow ambient storage for some days at the patient which caters to patient convenience and accessibility. For the first item narrow limits are needed, for the latter, wide limits are needed. This webinar will focus on the balance of the two lines of argumentation and introduces the concept of considering criticality of quality attributes for setting specifications.

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