September 20th - 21st, 2023
8:15 AM - 1:15 PM EDT
25 Charles St.
Boston, MA 02114
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 is back in Boston! This essential training course – now in its 41st 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 boot camp will include practical real-world examples that will help you to excel in your everyday practices.
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.
- 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
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.