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Duane Morris Partner Terry Gaffney to Speak at FDA Boot Camp
September 15, 2009 | Boston
| Omni Parker House
Duane Morris partner P. Terrence Gaffney will be a speaker at the FDA Boot Camp conference, to be held on September 15-16, 2009, at the Omni Parker Hotel in Boston. Mr. Gaffney's presentation will be on "Essential Requirements of the Clinical Trials Processes."
About the Conference
Increase your FDA regulatory knowledge to become a better life sciences products litigator or patent attorney
The approval process. . .pre-approval concerns. . .product labeling. . .clinical trials. . .adverse events reports. . .patent concerns. . .exclusivity. FDA law and regulations govern these critical aspects in the commercialization process for drugs, biologics, and devices. And with the ever-evolving regulations, new preemption case law, and pending legislation concerning FDA-regulated products on the horizon, it is essential for attorneys who do not have regulatory practices – but who deal with FDA-regulated products – to understand the rules and regulations that impact the life sciences arena.
The outcome of products liability and patent litigation concerning these products often hinges on what happened during the pre-approval, approval, or post-approval periods. Becoming well-versed in the essentials of the approval process and post-approval hurdles will enable you to much more effectively navigate the regulatory maze that plays a critical role in your cases and practice.
ACI's FDA Boot Camp, the industry standard in providing non-regulatory professionals with a regulatory background, has been designed to give products or patent litigators, as well as patent prosecutors and life sciences investment and securities experts, a strong working knowledge of core FDA regulatory competencies, including the nuances of the FDAAA.
A distinguished faculty of top FDA regulatory experts – a "Who's Who of the FDA Bar" – will share their knowledge and give you critical insights on:
- The organization, jurisdiction, functions, and operations of the FDA
- The essentials of the approval process for drugs, biologics, and devices, including:
- NDAs
- 505b2s
- INDs
- 510 K submissions
- BLAs
- MPA 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
Other program highlights include special tracks for patent attorneys and products litigators.
For more information or to register online, please visit the American Conference Institute website.
