For over 15 years, this Conference has been the Training Grounds for Life Sciences Attorneys and Executives to Master the Fundamentals of FDA Regulation.
It’s Time for You to Join Their Ranks.
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 37th iteration, 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.
LEARN FROM THE MASTERS
A distinguished faculty of top FDA regulatory authorities – a “Who’s Who of the FDA Bar” – will share their knowledge and provide you with critical insights on:
- The organization, jurisdiction, functions, and operations of FDA
- The essentials of the approval process for drugs and biologics
- The role of the Hatch-Waxman Act in the patenting of drugs and biologics
- Clinical trials for drugs and biologics
- Labeling in the drug and biologics approval process
- cGMPs and other manufacturing concerns relative to products liability
- Proactive adverse events monitoring and signal detection
- Recalls, product withdrawals, and FDA oversight authority