September 14th - 15th, 2022
8:15 AM - 1:30 PM EST
Or call 888-224-2480 for fastest service.
You can save extra 10% off the current rate by using code D10-999-JDS23.
Through nearly 19 years, ACI’s FDA Boot Camp has been the training grounds for life sciences attorneys and executives to master the fundamentals of FDA regulation. Don’t miss your opportunity to join their ranks.
2022 CONFERENCE CO-CHAIRS
The approval process…pre-approval concerns…product labeling…clinical trials…adverse events reports…patent concerns…and exclusivity – these are all critical aspects in the commercialization process for drugs and biologics that are governed by the FDA. Recent news stories and high-profile trials concerning FDA-regulated products have made it clear that it is critical for attorneys who do not have regulatory practices and life sciences executives who deal with FDA-regulated products to have a familiarity with these concepts.
For this reason, ACI’s FDA Boot Camp returns for its 39th iteration – in a fully virtual format – with the continued intent of providing these individuals with an essential working knowledge of core FDA concepts, and real-world examples that will help them to excel in their everyday practices.
Preeminent members of the nation’s Food and Drug bar will drill you in the essentials of FDA law and regulation and help you:
- 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-JDS23.
*Discount is valid for new registrations only and it’s not applicable for workshops.