Now in its 29th iteration, FDA Boot Camp is the premier event that will provide you with the ultimate roadmap to the complicated landscape of FDA regulatory law

This year’s FDA Boot Camp will provide you not only with the essential background in FDA regulatory law to help you in your practice, but also key sessions that show you how this regulatory knowledge can be applied to situations you encounter in real life.  Back by popular demand, this year’s “Ripped from the Headlines” session that will provide you with updates on the key developments in the FDA regulatory bar, including post-election developments and the impact of the new administration on FDA practice. ACI’s FDA Boot Camp has been designed by leading regulatory attorneys to give professionals such as, products or patent litigators, industry in-house counsel, business executives, investors, and regulatory affairs specialists 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 and biologics, including:
    • NDAs
    • INDs
    • BLAs
    • OTC Approval
    • 510(k) submissions
    • PMA process
  • Clinical trials for drugs and biologics
  • 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.   Our prior delegates say it best:
  • “Comprehensive overviews; invaluable resource; anticipate referencing slides often; good information.”
  • “This was an excellent CLE.  Highly informative!”
  • “It was great to attend an event that covered a broad spectrum of legal issues for our industry.  It will help me better understand what my colleagues are working on.”
  • “Effective presentation of key regulatory concepts facing pharmaceutical and medical device manufacturers.”
  • “Excellent conference!  I got exactly what I was hoping to get.”
  • “A wealth of information presented by knowledgeable individuals, providing numerous take aways that will be put to practical use.”
  • “GREAT! Nice balance between general overview and a couple of specifics without getting bogged down in details.”
  Based on past success, spaces will fill up quickly. Register now by calling 888-224-2480, faxing your registration form to 877-927-1563 or registering online.  


Millennium Broadway Hotel

145 W. 44th St., New York, NY 10036

Book Now