American Conference
Institute (ACI) will be holding its FDA Boot Camp Devices Edition conference on
November 4-5, 2013 in Chicago, IL. ACI
faculty will help attendees:
• Master the basics
of the application and approval processes, including 510(k) clearance and PMAs;
• Navigate the
complexities of device regulations;
• Comprehend the
structure of the FDA and the roles of the three major agency centers: CDER, CBER, and CDRH;
• Develop a
practical working knowledge of clinical trials and IDEs;
• Learn how devices
are classified, monitored, and regulated;
• Recognize the
pivotal role of labeling and learn how to avoid misbranding and off label
promotion;
• See the
importance of cGMPs and QSRs to the post-approval regulatory process; and
• Navigate the
protocols of adverse events monitoring, 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;
• Overview of
device regulation;
• Understanding
clinical trials and the investigational device exemption (IDE);
• Navigating the
510(k) clearance process;
• Comprehending the
premarket approval process (PMA);
• Complying with
general post-market controls;
• Understanding FDA
enforcement tools, policies, practices, and trends;
• Labeling and
promotion;
• Medical device
reporting;
• Guidance for
navigating recalls and withdrawals; and
• Quality system
regulation.
A pre-conference primer on the "Fundamentals of FDA Device Regulatory Law," will be offered on November 4, 2013 from 1:00 to 4:00 pm. A post-conference master class on "Unique Regulatory Schemes for Specialized Devices: Medical Device Software and Social Media Considerations in Advertising and Promotion" will be offered from 2:00 to 5:00 pm on November 6, 2013.
An agenda for the conference can be found here, and more information regarding the workshop and master class 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 master
class), or $3,295 (conference, workshop, and master class). Those registering by September 6, 2013 will
receive a $300 discount, and those registering by October 4, 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 [email protected], 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 Devices Edition conference.
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