ACI’s 40th FDA Boot Camp – March 22-23, 2023 (Virtual)

Hosted by American Conference Institute, the FDA Boot Camp returns for its 40th iteration with the continued intent of providing an essential working knowledge of core FDA concepts, and real-world examples that will help you to excel in your everyday practices.

This year’s conference co-chairs include Stacy Cline Amin (Partner, Morrison Forester) and Kurt R. Karst (Director, Hyman, Phelps & McNamara P.C.). Comprehend the structure of FDA and the roles of the three major agency centers: CDER, CBER and CDRH, master the basics of the application and approval processes for drugs and biologics, gain a practical working knowledge of clinical trial process for pharmaceutical products and much more! The distinguished speaker faculty includes Jennifer Bragg (Partner, Skadden Arps Slate Meagher & Flom LLP), Seth Mailhot (Partner, Husch Blackwell), Cathy L. Burgess (Partner, Alston & Bird LLP) and many, many more!

The speaker faculty of top FDA regulatory authorities will share 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

FDA Boot Camp is taking place virtually from March 22-23, 2023, visit http://bit.ly/3WxcEHs to learn more!

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