American Conference Institute's FDA Boot Camp will be held on July 21-23, 2009 at the Sutton Place Hotel in Chicago, IL. Join us to learn how the Obama administration, changing regulations, new preemption case law concerning FDA-regulated products and pending patent legislation impact companies dealing with FDA-regulated products. A faculty of FDA regulatory experts will provide products and patent litigators with a strong, working knowledge of core FDA regulatory competencies, including:
- The organization, jurisdiction, functions, and operations of the FDA
- The essentials of the approval processes for drugs, biologics, and devices, including:
- 510 K submissions
- PMA process
- ANDA applications
- Clinical trials for drugs and biologics and the clearance process for devices
- The classification of devices and the concept of "risk-based" classification
- The role of the Hatch-Waxman Act in the patenting of drugs and biologics
- Labeling in the drug and biological products approval process
- cGMPs and other manufacturing concerns relative to products liability
- Proactive adverse events monitoring
- Recalls, product withdrawals, and FDA oversight authority
David Gossett, partner in the Washington, DC office, will serve as co-presenter of the "Product Liability Master Class on Drug and Medical Device Preemption: Reconciling Wyeth, Riegel and the Medical Device Safety Act of 2009" on July 23rd, which will discuss drug and device preemption and what you can do to effectively assert this theory in the future.
For more information and to register, please visit www.AmericanConference.com.