Recorded April 1, 2020 | On-Demand Webinar
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.
his session was recorded as part of FDLI’s virtual Introduction to Biologics and Biosimilars Law and Regulation course in April 2020.