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. Rosen, Partner, Foley & Lardner LLP
This session was recorded as part of FDLI’s Virtual Introduction to Biologics and Biosimilars Laws and Regulations Course in March/April 2020.
- +$100 for nonmembers
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