Session – Nuts & Bolts: Regulation and Licensure Strategy

Time: 9:30AM – 10:30AM, Thursday, September 15, 2022
Location: Van Metre Hall Auditorium

This session will describe the regulatory process of developing and licensing a vaccine, from initial formulation through clinical trials, potential EUA authorization, full FDA licensure, and post-licensure inspection and policing of vaccines.

Speakers

Brian J. MalkinPartner, McDermott Will & Emory

Daniel A. Kracov, Co-Chair of the Life Sciences and Healthcare Regulatory practice, Arnold & Porter

Richard KinghamSenior Counsel, Covington & Burling LLP

Peter O. Safir, Senior Counsel, Covington & Burling LLP