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Periodic Risk-Benefit Evaluation Report

Simulate the role of a Regulatory Affairs manager in preparing a PRBER/PSUR for a newly approved/marketed drug/device combination product
Demonstrate understanding of the relevant requirements for post-market risk: benefit profile evaluation as outlined in ICH E2C(R2) for drugs/biologics, especially in the US and EU
Demonstrate understanding of the concept of risk: benefit as it relates to drug/biologic lifecycle management and the application of pharmacovigilance as a whole
Conceptualize of what it would be like to work cross-functionally at a small-to-midsize biotechnology company to educate coworkers on the relevant regulatory guidance for post-market PVG reporting specifically with respect to the PRBER/PSUR requirement