Overview
In this short course, we aim to introduce the basic concepts of comparative BR management based on industry’s best practices and the CIOMS XII guidance document. BR assessment has become an integrated part of any regulatory decision making for the marketing approval of medicinal products, as no product can be approved nor maintained if the BR profile is unfavorable. Most thinking about BR assessments used to focus on post-approval activities, but over the last years the emphasis has been extending to early development. We will show that BR assessments are multi-disciplinary in nature, requiring multi-stakeholder input and engagement, must be performed in a transparent way, and must be based on scientifically sound and robust evidence. When possible, subjective value judgements of key stakeholders may further inform the weighing and prioritization of key benefits and risks.
We will show the necessary steps in establishing and maintaining BR profiles for new and established therapeutic products, including examples and learnings from recent structured BR assessments in different settings.
Registered attendees for this Short Course will receive access to the course onsite and presentation materials.
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