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.

Nathan A. Beaver, Partner, Foley & Lardner LLP
Kyle Y. Faget, Partner, Foley & Lardner LLP

This session was recorded as part of FDLI’s Introduction to Biological Products, Including Vaccines, Biosimilars, Cell and Gene Therapies, and Other Advanced Therapies Course in October 2023. 


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