The American Conference Institute’s FDA Boot Camp returns for its 43rd iteration, continuing to provide the working knowledge of the core essentials of FDA law and regulation for life sciences attorneys, business executives and policy analysts. A distinguished faculty of top FDA regulatory leaders will cover topics including the Approval Process for Drugs and Biologics, Understanding the structure of FDA, the role of cGMPs, Advertising, Promotion, FDA Enforcement and Adverse Events, Hatch-Waxman and BPCIA Fundamentals and more.

On Thursday, March 20, WilmerHale Partner Timothy Cook will lead the “Hatch-Waxman and BPCIA in the Trenches: Exclusivity and Bioequivalency Working Group” workshop, building upon the content covered during the main conference on the regulatory and IP interplay in the Hatch-Waxman and Biologics Price Competition and Innovation Act schematics.