American Conference Institute's 22nd

FDA Boot Camp

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

Wednesday, March 12 to Thursday, March 13, 2014
DoubleTree Suites Times Square, New York, NY

American Conference Institute's 22nd

FDA Boot Camp

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

March 12-13, 2014 | Doubletree Suites Times Square | New York, NY

The approval process…pre-approval concerns…product labeling… clinical trials…adverse events reports… patent concerns… exclusivity –all are critical aspects in the commercialization process for drugs, biologics, and devices which are governed by FDA law and regulation.  Recent court cases, and high-profile trials concerning FDA-regulated products have made it clear that it is essential for attorneys who do not have regulatory practices — but who do deal with FDA-regulated products — to have a familiarity with these concepts.  The changing business dynamics of the life sciences industry have also made it critical for business executives, policy analysts and securities experts who work in this field to have a clear understanding of the dynamics of the FDA.

Litigation as well as numerous other legal, business, and policy decisions concerning FDA-regulated products often hinge on what happened during the pre-approval, approval, or post-approval periods.

Many products liability lawyers, patent counsel, business and investment experts, medical and regulatory affairs professionals, and those involved in pricing and reimbursement — despite their tenure in working with FDA-regulated products — are not well-versed in the essentials of the approval process and the regulatory hurdles of the post-approval period. Whether you are a products liability or patent litigator, in-house counsel, in-house business development or federal affairs professional, FDA Boot Camp will provide you the insights you need.

Boost your FDA regulatory IQ

Learn about the FDA approval process and the ins and outs of post-approval challenges

ACI’s FDA Boot Camp has been designed to give 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

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 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.

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.

For more information, please click here

 “I found the information was quite helpful and covered much material.” Kelli Davis, Senior Paralegal, Novo Nordisk, Inc. (2013 delegate) “Excellent conference!  I got exactly what I was hoping to get.”  (2013 delegate)Our prior delegates say it best:

  •  “A wealth of information presented by knowledgeable individuals, providing numerous take aways that will be put to practical use.” – Jonathan Cutty, Contract Specialist, Novo Nordisk, Inc. (2012 delegate)
  • “I thought it was very informative and relevant to my practice.” – Iciar P. Garcia, Corporate Counsel, Forest Laboratories, Inc. (2012 delegate)
  • “Wide and sufficient coverage of relevant topics.” – David Hutchinson, General Counsel, EMD Millipore (2012 delegate)
  •  “GREAT! Nice balance between general overview and a couple of specifics without getting bogged down in details.” – Stephen Kim, Corporate Counsel, Celgene Corporation (2012 delegate)

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

For information on sponsoring or exhibiting at this event, contact Wendy Tyler at