American Conference
Institute (ACI) will be holding the spring session of its FDA Boot Camp
conference on March 24-25, 2010 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 operations;
• 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);
• 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);
• 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.

A complete brochure
for this conference, including an agenda, list of speakers, and registration
form can be obtained here.

The registration
fee for this conference is $2,195. 
Those registering on or before February 19, 2010 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.