FDA Boot Camp

Join us for 2 days of lively discussion with experts of the FDA Bar and master the fundamentals of FDA law and regulation.

THIS YEAR’S HIGHLIGHTS

Preeminent members of the nation’s Food and Drug bar will drill you in the essentials of FDA law and regulation and help you:

• Navigating the Approval Process for Drugs and Biologics
• Clarifying the Clinical Trial Process for Drugs and Biologics
• Understanding the structure of FDA and the roles of the three major agency centers: CDER, CBER, and CDHR
• Hatch-Waxman and BPCIA Fundamentals: Understanding Follow-On Products and the Rules for Generic Entry
• cGMPs: Discovering the Unique Role of Current Good Manufacturing Practices (“cGMPs”) in the Post approval Process
• Advertising, Promotions, and Related First Amendment Concerns
• Understanding the Scope of FDA Enforcement Authority and Actions

About the Conference

ACI’s FDA Boot Camp is the premier platform for life sciences attorneys and executives to hone their expertise in FDA law and regulation.

This conference will equip legal professionals without prior regulatory expertise, as well as life sciences executives involved with FDA-regulated products, with a comprehensive understanding of fundamental FDA principles. This will be achieved by delivering firsthand insights, real-world examples, and case studies drawn from FDA-regulated products.

Join an esteemed panel of top FDA regulatory leaders as they cover all FDA essentials including the Approval Process for Drugs and Biologics, Understanding the structure of FDA, the role of cGMPs, Advertising, Promotion, FDA Enforcement and Adverse Events, Hatch-Waxman and BPCIA Fundamentals, and more.