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.
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.
Stacy Cline Amin
Morrison & Foerster
(Former Chief Counsel, U.S. FDA)
Kurt R. Karst
Hyman, Phelps & McNamara, P.C.
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
PRE & POST-CONFERENCE WORKSHOPS
Add more value to your conference experience by signing up for these hands-on and practical workshops and consider sending your team!
March 12, 2024
9:00 am – 12:00 pm
Medical Devices, Combination Products, and Companion Diagnostics Boot Camp: A Review of FDA Guidelines and Regulations
March 12, 2024
1:30 – 4:30 pm
March 14, 2024
2:30 – 5:30 pm
Workshops are offered In-Person only
Accreditation will be sought in those jurisdictions requested by the registrants which have continuing education requirements. This course is identified as non-transitional for the purposes of CLE accreditation. Learn more