American Conference Institute's 23rd

FDA Boot Camp

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

Thursday, September 18 to Friday, September 19, 2014
Omni Parker House Boston, Boston, MA


Now in its 23rd 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
    • 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

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. Get the background you need to fl ow 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.

Master Class C: Post-Approval Marketing Guidance and Preemption Protocols will address issues that arise post-approval, including advertising, promotion, and off-label promotion and enforcement, as well as preemption fundamentals.

Past iterations of the Boot Camp sold out; register now to ensure your place at this unique and important event.  Call 1-888-224-2480, fax your registration form to 1-877-927-1563 or log onto www.americanconference.com/fdabootcampbos.

If you are interested in speaking at this event, contact Chris Soverow at C.Soverow@americanconference.com.  For information on sponsoring or exhibiting at this event, contact Wendy Tyler at w.tyler@americanconference.com.