[Event] 42nd FDA Boot Camp

March 13th - 14th
New York, NY
American Conference Institute (ACI)
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March 13th - 14th, 2024
8:15 AM - 1:30 PM EDT
SpringHill Suites NY Manhattan Times Square South
338 West 36th Street
New York, NY 10018

Or call 888-224-2480 for fastest service.

You can save extra 10% off the current rate by using code D10-999-JDS24.

ACI’s FDA Boot Camp – now in its 42nd iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under the Food and Drug Omnibus Reform Act (FDORA). This in-depth training will include practical real-world examples that will help you to excel in your everyday practices.

CONFERENCE CO-CHAIRS

Speaker

Stacy Cline Amin

Partner

Morrison & Foerster

(Former Chief Counsel, U.S. FDA)

Kurt R. Karst

Kurt R. Karst

Director

Hyman, Phelps & McNamara, P.C.

For nearly 20 years, ACI’s FDA Boot Camp has been the Training Grounds for Life Sciences Attorneys and Executives to Master the Fundamentals of FDA Regulation. Join the “Who’s Who” of the FDA Bar and don’t miss your opportunity to join their ranks.

Conference Highlights Include:

Preeminent members of the nation’s Food and Drug bar will drill you in the essentials of FDA law and regulation and help you:

  • ADDRESS FDORA amendments to accelerated approvals and clinical trial diversity
  • COMPREHEND the structure of FDA and the roles of the three major agency centers: CDER, CBER, and CDHR
  • MASTER the basics 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 for pharmaceutical products
  • RECOGNIZE the pivotal role of labeling in the drugs and biologics approval process
  • DECIPHER the requirements for the advertising, marketing, and promotion of drugs and biologics
  • UNDERSTAND the importance of cGMPs to the post-approval regulatory process

Download the Brochure to see the full program including speaker faculty.

Save 10% off the current registration fee by using code D10-999-JDS24.

*Discount is valid for new registrations only and it’s not applicable for workshops.

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American Conference Institute (ACI)
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