American Conference Institute (ACI) will be holding the next session of its FDA Boot Camp conference on March 16-17, 2011 in New York, NY. ACI faculty will help attendees:
• Master the basics of the application and approval processes for drugs, biologics, and devices;
• Comprehend the structure of the FDA and the roles of the three major agency centers: CDER, CBER, and CDHR;
• Develop a practical working knowledge of clinical trials for drugs and biologics and the clearance process for devices;
• Learn how devices are classified, monitored, and regulated;
• Appreciate the complexities of pharmaceutical IP and the regulatory balance between brand name and generic products;
• Recognize the pivotal role of labeling in the drug and biologics approval process;
• See the importance of cGMPs to the post-approval regulatory process; and
• Navigate the protocols of adverse events monitoring, signal detection, product withdrawals, and recalls.
In particular, ACI's faculty will offer presentations on the following topics:
• The basics: Understanding and working with the FDA -- Jurisdiction, functions, organization, and operation;
• The nature of the approval process;
• Understanding the clinical trial process for drugs and biologics;
• Patent and IP overview for drugs and biologics: Hatch-Waxman, trade dress, and more;
• Drugs and biologics: Labeling;
• cGMPs: Drugs and biologics (current good manufacturing practices);
• Follow-on (comparable or biosimilar) biologics;
• Bioequivalence: What patent lawyers need to know (patent track);
• Challenges, opportunities, and current controversies with the (non-patent) marketing exclusivities;
• Adverse events monitoring, pharmac ovigilance and risk management;
• Medical devices: Classification and the essentials of the device premarket review process;
• Post-market requirements and concerns for medical devices; and
• Recall guidance for drugs, biologics, and medical devices: What you need to know.
A pre-conference workshop on the "Fundamentals of FDA Regulatory Law," will be offered on March 15, 2011. The workshop will provide a basic overview of FDA regulations and will prepare attendees for the in-depth discussions that will take place throughout the conference.
The agenda for ACI's FDA Boot Camp conference can be found here. A complete brochure for this conference, including an agenda, detailed descriptions of conference sessions, list of speakers, and registration form can be obtained here.
The registration fee is $2,295 (conference alone) or $2,895 (conference and pre-conference workshop). Those registering by February 17, 2011 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 partner of ACI's FDA Boot Camp conference.
Comments