From Product Characterization to Clinical Reliable Specifications

Defining product ranges needs 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.
Presented by André Mischo, Associate Director Science & Technology at Novartis

André Mischo holds a PhD in biochemistry. He is as keen on developing medicines as he was when he joined Novartis almost ten years back. Drug development has been his core activities, be it e.g. as particle lab team leader or as analytical project lead. André is driven by curiosity and he is involved in several initiatives e.g. involved in new modalities or in setting specifications that are relevant for patients.