March 24th - 25th, 2021
8:15 AM - 1:45 PM EDT
Or call 888-224-2480 for fastest service.
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
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Kurt R. Karst
Partner
Hyman, Phelps & McNamara, P.C.
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Torrey Cope
Partner
Sidley Austin LLP
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WHAT TO EXPECT AT THE VIRTUAL FDA BOOT CAMP
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Enjoy an Easy to Use, Dynamic Online Platform.
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Immerse Yourself in Live Presentations and Panel Discussions.
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Engage in meaningful dialogue with attendees and speakers in an interactive format.
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Meet 1:1 with Your Fellow Attendees. Expand your network and make new connections.
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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.