American Conference Institute is planning another "FDA Boot Camp" conference for May 15-16 in San Francisco. Prior versions of this conference in New York and Chicago were very popular.
According to ACI, "FDA Boot Camp has been designed to give product or patent litigators, as well as patent prosecutors and life sciences investment and securities experts, a strong working knowledge of core FDA regulatory competencies." The conference features top FDA regulatory experts from pharmaceutical companies and outside law firms.
Here are a few of the presentations on the agenda:
- The Basics: Understanding and Working with the FDA--Jurisdiction, Functions, Organization, and Operations
- The Nature of the Approval Process for Drugs, Biologics, and OTC Products
- Patent and IP Overview for Drugs and Biologics: Hatch-Waxman, Trade Dress, and More
- Drugs and Biologics: Labeling
- Non-patent Exclusivity
- Bioequivalence: What Patent Lawyers Need to Know
- Follow-on Biologics
The co-chairs for the conference are Peter Safir of Covington & Burling LLP and William Vodra of Arnold & Porter LLP, both of whom are well known food and drug lawyers.
Additional details and registration information are available at the conference website.
Orange Book Blog is a media partner of this conference.
Comments