American Conference
Institute (ACI) will be holding the next session of its FDA Boot Camp
conference on March 19-20, 2013 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;
• IP overview for
drugs and biologics:  Hatch-Waxman,
BPCIA, trade dress, and more:
• Part 1 —
Overview of patent and trademark issues;
• Part 2 —
Hatch-Waxman and BPCIA overview;
• Drugs and
biologics:  Labeling;
• cGMPs:  Drugs and biologics (current good manufacturing
practices);
• Medical
devices:  Classifications, the essentials
of the premarket review process, and post-market requirements and concerns;
• Adverse events
monitoring, pharmacovigilance and risk management; and
• Recall guidance
for drugs, biologics, and medical devices: 
What you need to know.

A pre-conference
workshop on the "Fundamentals of FDA Regulatory Law" and
"Resolving Ethical Challenges Encountered During the Drug Approval
Process" will be offered on March 18, 2013 from 1:00 to 5:00 pm.  The workshop will provide a basic overview of
FDA regulations and will prepare attendees for the in-depth discussions that
will take place throughout the conference, and explore ethical issues that may
arise in the context of communications with FDA on behalf of clients.

Two post-conference
master classes will be offered on March 20, 2013.  The first master class, entitled
"Hatch-Waxman and BPCIA: Overview of Biosimilars and Life Cycle Planning
for Drugs and Biologics," will provide an in-depth overview of biosimilars
as well as analyses of bioequivalence and exclusivities and their role in
patent and product life cycle management. 
The second master class, entitled "Post-Approval Marketing Guidance
and Preemption Protocols," will address issues that arise post-approval,
including advertising, promotion, and off-label promotion and enforcement, as
well as preemption fundamentals.

An agenda for the
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 is $2,295 (conference alone), $2,895 (conference and workshop or conference
and one master class), or $3,295 (conference, workshop, and one master
class).  Those registering by January 23,
2013 will receive a $300 discount and those registering by February 20, 2013
will receive a $200 discount.  Patent Docs readers who reference the
discount code "PD 200" will receive $200 off the current price tier
when registering.  Those interested in
registering for the conference can do so here, by
e-mailing CustomerService@AmericanConference.com, 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.