Orange Book Blog

American Conference Institute will be holding another "FDA Boot Camp" in Boston, September 22-23.

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.  The conference features FDA regulatory and patent law experts from pharmaceutical companies and outside law firms.

Talks on the agenda include:

• The Basics: Understanding and Working with the FDA — Jurisdiction, Functions, Organization, and Operations
• The Nature of the Approval Process
• Understanding the Clinical Trial Process for Drugs and Biologics
• Patent and IP Overview: Hatch-Waxman, Trademark Protection, and More
• Non-Patent Exclusivity (I'll be presenting this one)
• Bioequivalence: What Lawyers Need to Know
• Follow-On (Comparable or Biosimilar) Biologics

For more information or to register, please visit the conference website.

Orange Book Blog readers can save $200 on registration with code SP1.