ACI’s FDA Boot Camp – September 14-15, 2022 (Virtual)August 5, 2022
The American Conference Institute is hosting their 39th FDA Boot Camp from September 14-15, 2022. The conference will be held virtually.
Gain insight and training in core regulatory concepts for life sciences attorneys, business executives, and policy analysts.
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. It is important 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.
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:
- 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
Register today (here) and save 10% with the FDA Law Blog promo code: D10-999-FDALAWBLOG.