American Conference Institute (ACI) will be holding the next session of its FDA Boot Camp conference on September 22-23 in Boston, MA.  The conference will allow attendees to:

• 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 CDER, CBER, & CDRH;
• Develop a practical working knowledge of clinical trials for drugs and biologics and the clearance process for devices;
• Appreciate the regulatory balance between brand name and generic products;
• Understand the complexities of the patent and IP landscape, including the Hatch-Waxman Act, Orange Book, 180-day exclusivity, 30-month stay, Paragraph IV, NDA, ANDA, and 505(b)(2);
• Recognize the role of labeling in the drug/biological product approval process;
• See the importance of cGMPs to the post-approval regulatory process;
• Navigate the protocols of adverse events monitoring, pharmacovigilance, and Risk Evaluation and Minimization Strategies (REMS);
• Learn how devices are classified, monitored, and regulated; and
• Explore the FDA's expectations and guidance for 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 operations;
• The nature of the approval process;
• Understanding the clinical trial process for drugs and biologics;
• Patent and IP overview:  Hatch-Waxman, trade dress, and more;
• Drugs and biological products:  Labeling;
• cGMPs:  Drugs and biologics (current good manufacturing practices);
• 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)
• Adverse events monitoring, pharmacovigilance, and risk management;
• Medical devices:  Classification and the essentials of the device premarket review process;
• Post-market requirements and concerns for medical devices;
• Medical device labeling and advertising; and
• Recall guidance for drugs, biologics, and medical devices:  What you need to know.

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 for the conference is $2,195.  Those registering on or before July 18, 2008 will receive a $300 discount, and those registering on or before August 29, 2008 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.