Risk Minimization Action Plans (Risk MAPs) evolve as clinical and safety data emerge in a product’s lifecycle. Risk MAPs should begin to be developed as early in the product life cycle as possible, prior to an NDA filing. The phase 3 time period offers an opportunity to inform a post-marketing risk minimization program. This webinar will teach you how to:
•Incorporate a Risk MAP within a pre-marketing clinical trial;
•Evaluate clinical trial data as a basis for developing a RiskMAP strategy; and
•Use the phase 3 program to test and refine Risk MAP tools.