As we noted last month, American Conference Institute (ACI) will be holding the next installment of its FDA Boot Camp conference on July 21-22, 2009 in Chicago, IL. Designed to provide patent attorneys with a comprehensive overview of the basics of Fodd and Drug Administration law, this conference will help attendees gain a better understanding of the underlying regulatory processes with which drugmakers must comply. The conference covers the entire product approval life cycle, from pre-approval and approval thru post-approval, and includes a bifurcated track for patent attorneys that will address non-patent exclusivity, bioequivalence, and follow-on biologics. The conference will also address the following topics:
• The structure of the FDA and the roles of the three major agency centers: CDER, CBER, and CDHR;
• Clinical trials for drugs and biologics and the clearance process for devices;
• How devices are classified, monitored, and regulated;
• The complexities of pharmaceutical IP and the regulatory balance between brand name and generic products;
• The importance of cGMPs to the post-approval regulatory process;
• How to best navigate the protocols of adverse events monitoring, signal detection, product withdrawals, and recall; and
• What impact recent legislative and caselaw developments in the area of drug and biologic import/export guidelines will have on you and your clients.
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.
While the standard registration fee for the conference ranges from $2195 (conference alone) to $2795 (conference and workshop), ACI will be providing a $500 discount to anyone registering on or before June 19, 2009 when they reference the discount code "Patent Docs." 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.
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