Now in its 28th iteration, FDA Boot Camp is the premier event that will provide you with the ultimate roadmap to the complicated landscape of FDA regulatory law

  BACK BY POPULAR DEMAND: This year’s FDA Boot Camp has been designed to not only provide you with the essential background in FDA regulatory law, but also to provide key sessions that show you how to apply the regulatory knowledge to situations you encounter in real life. Highlights of this year’s program include the “Ripped from the Headlines” sessions that will update you on key developments in the FDA regulatory bar, and “The Marketing Pendulum Has Swung” which will focus on case studies analyzing off label civil and criminal enforcement activity.   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
    • BLAs
    • OTC Approval
    • INDs – 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
  Attend the pre-conference workshop or post-conference master class to get the background and/or the in-depth information you need to maximize your learning and networking experience at this event! Workshop A: Fundamentals of FDA Regulatory Law will address topics to set the stage for the main conference by helping you thoroughly comprehend the structure of the FDA and the essentials of the pre-approval, approval, and post-approval process. Get the background you need to flow seamlessly into the conversations at FDA Boot Camp. This workshop also includes a session on Resolving Ethical Challenges Encountered During the Drug Approval Process which will explore how to navigate situations where FDA requires full disclosure of adverse information and authority while maintaining your duty of care to clients.   Workshop B: Hatch-Waxman and BPCIA in the Trenches: Deconstructing and Constructing an Exclusivity Dispute will provide an in-depth overview of biosimilars as well as analyses of bioequivalency and exclusivities and their role in patent and product life cycle management.   Attend this conference and learn to navigate your way through the regulatory maze that plays such a crucial role to your cases and practice areas.   Seats at prior iterations of FDA Boot Camp sold out. Don’t delay—REGISTER NOW Call: 888-224-2480


Omni Parker House

60 School Street, Boston, MA 02108

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