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 require
Assignment description: In completing Assignment #3, students will have the opportunity to: 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 […]