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.
Abeba Habtemariam, Counsel, Arnold & Porter 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 March 2022.