On-Demand Virtual Conference

Due to social distancing and large group gathering restrictions, ACI’s FDA Boot Camp Boston changed its format from an in-person event to a live and interactive virtual conference. If you missed the conference, you can still purchase the recording and watch on your schedule. Watch from wherever you may be, access information delivered by our expert speaker faculty as you would at an onsite event.

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For over 15 years, this Conference has been the Training Grounds for Life Sciences Attorneys and Executives to Master the Fundamentals of FDA Regulation.

It’s Time for You to Join Their Ranks.

The approval process…pre-approval concerns…product labeling…clinical trials…adverse events reports…patent concerns… and exclusivity — these are all critical aspects in the commercialization process for drugs and biologics that are governed by the FDA. Recent news stories and high-profile trials concerning FDA-regulated products have made it clear that it is critical for attorneys who do not have regulatory practices and life sciences executives who deal with FDA-regulated products to have a familiarity with these concepts.

For this reason, ACI’s FDA Boot Camp returns for its 35th iteration, in a fully virtual format, with the continued intent of providing these individuals with an essential working knowledge of core FDA concepts, and real world examples that will help them to excel in their everyday practices.

Kurt R. Karst

Kurt R. Karst

Hyman, Phelps & McNamara, P.C.

Rebecca K. Wood

Rebecca K. Wood

Sidley Austin LLP
(Former Chief Counsel, U.S. Food and Drug Administration)

A distinguished faculty of top FDA regulatory authorities – a “Who’s Who of the FDA Bar” – will share their knowledge and provide you with critical insights on:
  • The organization, jurisdiction, functions, and operations of FDA
  • The essentials of the approval process for drugs and biologics
  • The role of the Hatch-Waxman Act in the patenting of drugs and biologics
  • Clinical trials for 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

In addition, our updated agenda offers advanced guidance sessions focusing on new approval requirements under FDARA and the 21st Century Cures Act, advertising and promotion guidelines for pharmaceuticals and biologics, and a look at the latest initiatives and policies of the FDA.

  • Expedited Approvals: Chasing the COVID-19 Vaccine
  • Controlled Substances

Learn to navigate your way through the regulatory maze that plays such a crucial role to your cases and practice areas.

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Join Us In 2021

Leading FDA counsel and top regulatory executives will convene again in 2021 for the 36th FDA Boot Camp.

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The ACI Boot Camp covers all the basics by the experts. The speakers are what give this conference life.

Travis Thayer
Sr. Regulatory Associate, Chiesi USA
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This event offers a unique combination of experienced faculty, a comprehensive and up-to-date program, and concise and practical content. For any practitioner in the FDA space who wants to get a powerful learning boost in a compact package, this is a great program to attend.

Second co-chair, Christopher M. Mikson
Partner, Mayer Brown
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The ACI Boot Camp is the perfect way to learn how to navigate the complexities of the FDA regulatory process that is so critical throughout the life cycle of drugs and biologics.

Saira Haider
Patent Attorney, Fresenius Kabi
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Excellent conference with talented speakers who hold a wealth of knowledge.

Timothy Benoit-Ledoux
Legal Counsel, Vapotherm