Obtain the guidance you need to master the difficult area of FDA regulatory law

Having a firm understanding of the critical FDA regulatory aspects of the commercialization process for biopharmaceutical products and medical devices, including the pre-approval and approval processes, product labeling, clinical trials, patent concerns and exclusivity is a critical competency for every attorney and executive in the life sciences industry. Recent news stories and highly publicized trials related to FDA-regulated products show the necessity of having a strong familiarity with these concepts. ACI’s FDA Boot Camp returns to Boston with the goal of providing these individuals with a core working knowledge of essential FDA concepts, and real-world examples that will guide them in their everyday practices.

New for 2019 – Special Focus Sessions on:

  • The FDA’s Digital Health Initiatives
  • Opioid and Other Controlled Substances Classifications
  • The Impact of FDARA on Drug Approvals

Distinguished counsel of the Food and Drug bar will drill you in the essential elements of the FDA law and regulation and help you:

  • MASTER the core competencies of the application and approval processes for drugs and biologics
  • APPRECIATE the complexities of pharmaceutical IP and the regulatory balance between brand name and generic products
  • GAIN a practical working knowledge of clinical trial process
  • RECOGNIZE the pivotal role of labeling
  • DECIPHER the requirements for advertising, marketing, and promotion of drugs and biologics
  • UNDERSTAND the importance of cGMPs to the post-approval regulatory process
  • NAVIGATE the protocols of adverse events monitoring, signal detection, product withdrawals, and recalls

Maximize your knowledge and networking experience at the pre-conference primer, ethics session, and post-conference skills session:

    September 17, 2019

  1. FDA Law 101 (with Ethics Bonus): A Guide to Agency Structure, Jurisdictions, Regulation, and Applicable Law
  2. Medical Devices, Combination Products, and Companion Diagnostics Boot Camp: A Guide to FDA Guidelines and Regulations
  3. September 19, 2019

  4. Hatch-Waxman and BPCIA in the Trenches: Exclusivity and Bioequivalency Working Group

OUR PRIOR DELEGATES SAY IT BEST:

“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
“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
“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
“Excellent conference with talented speakers who hold a wealth of knowledge.”
Timothy Benoit-Ledoux, Legal Counsel, Vapotherm

Don’t miss your opportunity to save with Early Bird rates!

Get the ALL ACCESS PASS to include all 3 Workshops and SAVE MORE!

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