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.
Nathan A. Beaver, Partner, Foley & Lardner 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 October 2022.
NATHAN A. BEAVER is a partner and food and drug lawyer with Foley & Lardner LLP, where his practice focuses on the representation of companies whose products and activities are regulated by the Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), US Department of Agriculture (USDA) and the Federal Trade Commission (FTC). He advises clients on regulatory issues affecting prescription and over-the-counter drug products (including animal drugs), medical devices, dietary supplements, cosmetics and foods. Nate is a member of the firm’s Government Solutions and FDA Practices and the co-chair of the Food & Beverage Industry Team. He is also a member of the Cannabis and Life Science Industry Teams.Get Access
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