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Post-Approval Pharmacovigilance: An Introduction

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Recorded October 27, 2022 | On-Demand Webinar

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.

This session was recorded as part of FDLI’s virtual course, "Introduction to Biological Products, Including Vaccines, Biosimilars, Cell and Gene Therapies, and Other Advanced Therapies" in October 2022.

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