Orange Book Blog

American Conference Institute’s popular "FDA Boot Camp" returns to the University of Chicago’s Gleacher Center in downtown Chicago on September 25-26.  ACI expects a sell-out of this conference and recommends early registration.

The conference is designed to give patent lawyers, product liability lawyers, and life sciences investment and securities experts a strong working knowledge of core FDA regulatory competencies.  It features FDA regulatory and patent law experts from pharmaceutical companies and outside law firms.

Presentations on the agenda include:

• The Basics: Understanding and Working with the FDA–Jurisdiction, Functions, Organization, and Operations
• The Nature of the Approval Process
• Patent and IP Overview for Drugs and Biologics: Hatch-Waxman, Trade Dress, and More (I’ll be on this panel, speaking about Hatch-Waxman)
• Drugs and Biologics: Labeling
• Non-patent Exclusivity
• Bioequivalence: What Patent Lawyers Need to Know
• Follow-on Biologics
• Medical Devices: Classification and the Essentials of the Device Premarket Review Process

The co-chairs of the conference are Coleen Klasmeier of Sidley Austin LLP and Erika Lietzan of Covington & Burling LLP.  Additional details and registration information are available at the ACI FDA Boot Camp web site.

Orange Book Blog is a media partner of this conference.