Post-Approval Pharmacovigilance of Biological Products: An Introduction

Learn the regulatory basis of post-marketing adverse event reporting and become familiar with how CBER conducts these activities, including active and passive surveillance. Recognize the regulatory basis of post-marketing commitments and requirements, risk evaluation and mitigation strategies (REMS), and understand how CBER implements these tools to enhance post-licensure safety of biologics.

David L. Rosen, Partner, Foley & Lardner LLP

This session was recorded as part of FDLI’s Introduction to Biologics: Vaccines, Biosimilars, Cell and Gene Therapies, and More Course in March 2024.

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