American Conference
Institute (ACI) will be holding the next session of its FDA Boot Camp
conference on September 27-28, 2010 in Boston, MA.  ACI faculty will help attendees:

• Master the
complexities of pharmaceutical iP and the regulatory balance between brand name
and generic products;
• Analyze the
future of follow-on biologics following recent health care reform legislation;
• Recognize the
pivotal role of labeling in the drug and biologics approval process;
• Comprehend the
structure of the FDA and the roles of the three major agency centers:  CDER, CBER, and CDHR;
• Understand the
basics of the approval processes for drugs, biologics and devices, including
in-depth discussion of the application, pre-approval and post-approval requirements;
• Evaluate when
preemption arguments may offer protection for life sciences companies;
• Assess what
marketing activities may constitute off-label promotion;
• Navigate the
protocols of adverse events reporting; and
• Develop a
practical working knowledge of clinical trials for drugs and biologics and the
clearance process for devices.

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;
• Spotlight on
follow-on (comparable or biosimilar) biologics and the 2010 health care reform
legislation;
• Drugs and
biologics:  Labeling;
• Preemption
fundamentals;
• Marketing and
promotion;
• Non-patent
exclusivity (part of the conference's patent track);
•
Bioequivalence:  What patent lawyers
need to know (patent track);
• Adverse events monitoring,
pharmacovigilance and risk management; and
• Medical device
essentials:  Premarket and
post-market requirements.

The agenda for the
Maximizing Pharmaceutical Patent Lifecycles conference can be found here.  A complete brochure for this
conference, including an agenda, detailed descriptions of conference sessions, list
of speakers, and registration form can be obtained here.

The registration
fee for this conference is $2,195. 
Those registering by August 27, 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.