Post-Approval Pharmacovigilance of Biological Products: An Introduction
A session from FDLI’s Introduction to Biologics: Vaccines, Biosimilars, Cell and Gene Therapies, and More
Recorded March 5–6, 2024
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.
David L. Rosen, Partner, Foley & Lardner LLP
This session was recorded as part of FDLI’s Introduction to Biologics: Vaccines, Biosimilars, Cell and Gene Therapies, and More Course in March 2024.
DAVID L. ROSEN is a partner and public policy lawyer with Foley & Lardner LLP. He has extensive experience in health law, life sciences and food and drug regulation, including a range of Food and Drug Administration (FDA) regulatory issues affecting prescription and over-the-counter pharmaceuticals, medical devices and biologics. He is co-chair of the firm’s Life Sciences Industry Team and is also a member of the firm’s Government & Public Policy Practice and the Health Care and Food & Beverage Industry Teams. David was formerly a partner with two other law firms. He was also employed by the FDA for 14 years, progressing to various supervisory positions involving virtually all aspects related to the drug approval process, combination products, jurisdictional issues and related compliance activities.Get Access
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