American Conference Institute (ACI) will be holding its fall session of the FDA Boot Camp conference on September 15-16, 2009 in Boston, MA. The conference will provide information on:
• The organization, jurisdiction, functions, and operations of the FDA;
• The essentials of the approval process for drugs, biologics, and devices, including: NDAs, 505b2s, INDs, 510 K submissions, BLAs, MPA process, and ANDA applications;
• Clinical trials for drugs and biologics and the clearance process for devices;
• The classification of devices and the concept of "risk-based" classification;
• The role of the Hatch-Waxman Act in the patenting of drugs and biologics;
• Labeling in the drug and biological products approval processl;
• cGMPs and other manufacturing concerns relative to products liability;
• Proactive adverse events monitoring; and
• Recalls, product withdrawals, and FDA oversight authority.
In particular, ACI's faculty will offer presentations on the following topics:
• The basics: Understanding and working with the FDA and the New Administration -- Jurisdiction, functions, organizations & operations;
• 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 products, and medical device 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) -- to be presented by MBHB colleague 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; and
• Recalls and withdrawals.
An additional post-conference workshop entitled: "Spotlight on Nanotechnology" will be offered on September 16, 2009. The workshop will address the following topics:
• A comprehensive overview of current and proposed FDA policies on nanotechnology regulation;
• National Nanotechnology Initiative;
• Potential legislation to regulate nano products; and
• Classifying nano products for FDA approval.
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 obtained here.
The registration fee ranges from $2,195 (conference) to $2,695 (conference plus workshop). Those registering on or before August 14, 2009 will receive a $200 discount, and those registering on or before July 17, 2009 will receive a $300 discount. ACI will provide a $600 discount off the standard price to all Patent Docs readers who reference the discount code "The Media Partner Discount" when registering. 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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