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Vaccine Enforcement and Litigation

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Recorded February 4, 2021 | On-Demand Webinar

A last consideration of vaccine development is possible exposure to enforcement actions, which can include warning letters, recalls, civil penalties, or criminal prosecutions. The Public Readiness and Emergency Preparedness (PREP) Act provides targeted liability immunity to covered entities for measures taken in relation to certain countermeasures during a public health emergency. This session will discuss the above enforcement and litigation concepts and provide examples related to COVID-19.

This session was recorded as part of FDLI’s virtual course, "Fundamentals of Vaccine Regulation: Scientific Ingenuity and Rigorous Review" in February 2021.

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