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Food and Drug Law Institute’s (FDLI) Fundamentals of Vaccine Regulation: Scientific Ingenuity and Rigorous Review

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Thursday, February 4, 2021
02:45–03:45 PM ET and 03:45–04:00 PM ET


After many months of enduring the profound effects of COVID-19, the U.S. is looking with hope toward the lifesaving benefits of a vaccine or vaccines. Development, clinical testing, and FDA’s emergency authorization of COVID-19 vaccines have occurred at a record pace while continuing to ensure safety and efficacy. How does FDA regulate vaccines, and how does the vaccine approval process differ from emergency authorization?

Speakers will discuss topics such as clinical trial development, ensuring safety and efficacy in a diverse study population, manufacturing supply chain and scaling considerations, logistical issues in vaccine distribution and administration to a large population, adverse event reporting requirements, and navigating possible liability issues, among other topics. COVID-19 vaccine examples will be discussed throughout the course.

Kathy will speak on “Manufacturing, Scaling, and Supply Chain Issues” and “Administration of Vaccine.”

The slides from this presentation are part of FDLI’s Fundamentals of Vaccine Regulation: Scientific Ingenuity and Rigorous Review course, available at https://www.fdli.org/on-demand-catalog/.