American Conference Institute (ACI) will be holding the next session of its FDA Boot Camp conference on July 21-22, 2009 in Chicago, IL. The conference will allow attendees to:
• 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;
• Navigate the protocols of adverse events monitoring, signal detection, product withdrawals, and recalls; and
• Understand the implications of recent legislative and caselaw developments in the area of drug and biologic import/export guidelines.
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 -- to be presented by MBHB colleague and Orange Book Blog author Aaron Barkoff;
• Drugs, biological products: Labeling;
• Current good manufacturing practices (cGMPs) and quality system regulation (QSR);
• Import/export guidelines & emerging international regulatory concerns;
• Non-patent exclusivity (part of the conference's patent track);
• Bioequivalence: What patent lawyers need to know (patent track);
• Follow-on (comparable or biosimilar) biologics (patent track);
• 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
• Recalls guidance for drugs, biologics, and medical devices.
An additional post-conference master class entitled: "Product Liability Master Class on Drug and Medical Device Preemption: Reconciling Wyeth, Riegel and the Medical Device Safety Act of 2009" will be offered on July 23, 2009. The master class will analyze the nuances of recent court decisions regarding preemption and provide insights into how to use these cases effectively in future litigation.
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 $2,795 (conference) to $2,195 (conference plus workshop). Those registering on or before June 19, 2009 will receive a $200 discount, and those registering on or before May 15, 2009 will receive a $300 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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