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Save extra 10% off the current rate by using code D10-999-JDS21.

ACI’s FDA Boot Camp returns in a completely interactive virtual format to help life sciences attorneys and executives to master the fundamentals of FDA Regulation.

Conference Co-Chairs

WHAT TO EXPECT AT THE VIRTUAL FDA BOOT CAMP

Gain essential working knowledge of core FDA concepts, and real-world examples that will help you excel in your everyday practices.

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.

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
• Clinical trials for drugs and biologics
• The role of the Hatch-Waxman Act in the patenting of 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

SPECIAL FOCUS SESSIONS ON

• Expedited Approvals: Chasing the COVID-19 Vaccine
• Controlled Substances

Download the Agenda to see the full program including speaker faculty.

Save an extra 10% off the conference by using code D10-999-JDS21.

*Discount is valid for new registrations only and it’s not applicable for workshops.