American Conference Institute (ACI) will be holding the next session of its FDA Boot Camp conference on March 30-31, 2009 in New York, NY. The conference will allow attendees to:
• Comprehend the structure of the FDA and the roles of the CDER, CBER, & CDRH;
• Gain a practical working knowledge of the essential clinical trials processes
for drugs and biologics, and the clearance process for devices;
• Uunderstand how devices are classified, monitored, and regulated;
• Explore the pivotal role of labeling in the drug and biologics approval process;
• Appreciate the complexities of pharmaceutical IP and the regulatory balance between brand name and generic products;
• Uncover the importance of cGMPs to the post-approval regulatory process;
• Learn to navigate the protocols of adverse events monitoring, signal detection, product withdrawals, and recalls;
• Discover the changing legal landscape of the defense of preemption; and
• Analyze the future of follow-on biologics.
In particular, ACI's faculty will offer presentations on the following topics:
• The nature of the approval process;
• Essential requirements of the clinical trials processes;
• Patent & IP spotlight: Hatch-Waxman, the patenting process, and more;
• Drugs, biological, and medical device products: Labeling;
• Current good manufacturing practices (cGMPs) and quality system regulation (QSR);
• Non-patent exclusivity (part of the conference's patent track) -- to be presented by MBHB colleague and Orange Book Blog author Aaron Barkoff;
• Bioequivalence: What patent lawyers need to know (patent track);
• Follow-on (comparable or biosimilar) biologics (patent track);
• Import/export guidelines & emerging international regulatory concerns
• Adverse events monitoring, pharmacovigilance, and risk management; and
• Recalls and withdrawals.
Two additional post-conference workshops will also be offered. Workshop A, entitled "Nanotechnology Spotlight: Regulatory Oversight and Legislative Initiatives," will provide information regarding current and proposed FDA policies and opinion on nanotechnology regulation, the National Nanotechnology Initiative, creating new legislation to regulate nano products, and classifying nano products for FDA approval. Workshop B, entitled "From the Trenches: Practical Strategies for Applying FDA Regulations to Real-World Matters," will discuss and debate legal issues submitted by delegates.
The agenda for the FDA Boot Camp conference can be found here. A complete brochure for this conference, including an agenda, list of speakers, and registration form can be downloaded here.
The registration fee ranges from $2,195 (conference) to $2,695 (conference plus one workshop). Those registering on or before February 27, 2009 will receive a $200 discount. Those interested in registering for the conference can do so here, by calling 1-888-224-2480, or by faxing a registration form to 1-877-927-1563.
Patent Docs is a media sponsor of ACI's FDA Boot Camp conference.
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