Our 2024 event has concluded.
Thank you to those who joined us in New York!
Stay tuned for more information about our upcoming event. We look forward to bringing you another exceptional conference next year and look forward to returning in March 2025!
OUR 2025 PROGRAM IS IN DEVELOPMENT
2024 CONFERENCE CO-CHAIRS
Stacy Cline Amin
Partner
Morrison & Foerster
(Former Chief Counsel, U.S. FDA)
Kurt R. Karst
Director
Hyman, Phelps & McNamara, P.C.
2024 CONFERENCE HIGHLIGHTS
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
About the Conference
ACI’s FDA Boot Camp has been the premier training ground for life sciences attorneys and executives to master the fundamentals of FDA law and regulation. Now in its 43rd iteration, our program continues to deliver essential knowledge, including the latest amendments under the Food and Drug Omnibus Reform Act (FDORA). With practical, real-world examples, our in-depth training is designed to help you excel in your everyday practices. Join the “Who’s Who” of the FDA Bar and seize the opportunity to advance your expertise.
CLE ACCREDITATION
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