American Conference Institute\'s

28th Annual FDA Boot Camp Boston

Basic training in core regulatory concepts for life sciences lawyers, business executives, scientists, and policy analysts

Wednesday, September 21 to Friday, September 23, 2016
Omni Parker House, Boston, MA

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

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
    • OTC Approval
    • INDs
    • 510(k) submissions
    • BLAs
    • 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
  • Promotion, advertising, and off-label marketing, including potential civil and criminal liability

Attend the pre-conference workshop or post-conference master classes 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. This workshop also features Resolving Ethical Challenges Encountered During the Drug Approval Process to help you examine ethical issues arising when communicating with the FDA on behalf of clients. Get the background you need to flow seamlessly into the conversations at FDA Boot Camp.

Master Class B: Hatch-Waxman and BPCIA: Overview of Biosimilars and Life Cycle Planning for Drugs and Biologics 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 ACI’s FDA Boot Camp sold out. Don’t delay — register now by calling 1-888-224-2480, faxing your registration form to 1-877-927-1563, or registering online.