A Who’s Who of the nation’s Food and Drug bar will drill you in the basics
of FDA law and regulation as they help you:
- MASTER the complexities of pharmaceutical IP and the regulatory balance between brand name and generic products
- ANALYZE the future of follow-on biologics following recent health care reform legislation
- RECOGNIZE the pivotal role of labeling in the drug and biologics approval process
- COMPREHEND the structure of the FDA and the roles of the three major agency centers: CDER, CBER, and CDHR
- UNDERSTAND the basics of the approval processes for drugs, biologics and devices, including in-depth discussion of the application, pre-approval
and post-approval requirements
- EVALUATE when preemption arguments may offer protection for life sciences companies
- ASSESS what marketing activities may constitute off-label promotion
- NAVIGATE the protocols of adverse events reporting
- DEVELOP a practical working knowledge of clinical trials for drugs and biologics and the clearance process for devices
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. Recent court cases and high-profile litigation concerning FDA-regulated products have made it clear that it is essential for attorneys who do not have regulatory practices – but who deal with FDAregulated products – to understand the rules and regulations that impact the life sciences arena.
Products liability and patent litigation concerning FDA-regulated 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.
Boost your FDA regulatory IQ.
Understand the FDA approval process and the ins and outs
of post-approval challenges.
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.
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
- INDs
- BLAs
- ANDA applications
- 505b2s
- 510 K submissions
- PMA process
- 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
- Preemption arguments currently being debated by the courts
- Proactive adverse events monitoring
- Regulation of advertising and particular concerns relating to off-label promotion
Other program highlights include special tracks for Patent Attorneys and Products Litigators.
Attend this conference and learn to navigate the regulatory concepts that play such a crucial role in your practice area. This program has sold out twice recently in New York and is rarely offered on the West Coast. Register today by calling 1-888-224-2480, you also can fax your registration form to 1-877-927-1563, or go online.
Conference Details
