American Conference Institute's popular "FDA Boot Camp" comes to Boston on July 17-18. According to ACI, seats at this year's New York and last year's Chicago editions sold out.
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 top FDA regulatory 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
- Understanding the Clinical Trial Process for Drugs and Biologics
- Patent and IP Overview for Drugs and Biologics: Hatch-Waxman, Trade Dress, and More
- Drugs and Biologics: Labeling
- Medical Devices: Classification and the Essentials of the Device Premarket Review Process
The chair for the conference is Michael P. Peskoe of Edwards Angell Palmer & Dodge LLP. Additional details and registration information are available at the conference website.
Orange Book Blog is a media partner of this conference.
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