ACI’s FDA Boot Camp has been designed by leading regulatory attorneys to give professionals that work in conjunction with the pharmaceutical, biologics, and medical devices industries — such as products or patent litigators, as well as patent prosecutors, industry in-house counsel, and life sciences investment and securities experts — a strong working knowledge of core FDA competencies.

A distinguished faculty of top FDA regulatory experts — a “Who’s Who of the FDA Bar” — will share their knowledge and give you critical insights on:

• The organization, jurisdiction, functions, and operations of the FDA
• The essentials of the approval process for drugs, biologics, and devices, including:
  • NDAs
  • INDs
  • BLAs
  • OTC Approval
  • 510(k) submissions
  • PMA process
• Clinical trials for drugs and biologics and the clearance process for devices
• The classification of devices and the concept of “risk-based” classification
• The role of the Hatch-Waxman Act in the patenting of drugs and biologics
• Labeling in the drug and biologics approval process
• cGMPs and other manufacturing concerns relative to products liability
• Proactive adverse events monitoring and signal detection
• Recalls, product withdrawals, and FDA oversight authority

Join Reed Smith Counsel, James Beck, for his presentation entitled "Preemption Fundamentals."

Download the PDF for additional information.