FDA Boot Camp

For over 15 years, this Conference has been the Training Grounds for Life Sciences Attorneys and Executives to Master the Fundamentals of FDA Law and Regulation. It’s Time for You to Join Their Ranks.

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. 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