Post-Approval Pharmacovigilance of Biological Products: An Introduction

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

David L. Chesney, Principal and GM, DL Chesney Consulting, LLC

This session was recorded as part of FDLI’s Virtual Introduction to Biologics and Biosimilars Laws and Regulations Course in October 2021. 


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