• 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.
• 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 training session on the "Fundamentals of FDA Regulatory Law," will be offered on October 24, 2011 from 1:00 - 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.
Two concurrent post-conference master classes will be offered from 2:00 - 5:00 pm on October 26, 2011. The first master class, entitled "Staying Ahead of the Curve: FDA's Regulation of In Vitro Diagnostics and Laboratory Developed Tests," will provide an in-depth overview of the FDA regulatory structure governing IVDs, and the coming changes that will regulate LDTs. The second master class, entitled "Software as a Medical Device: Understanding the Nuances of FDA Regulation," will address issues that are encountered when dealing with software classified as medical devices.
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 training session or conference and one master class), or $3,295 (conference, training session, and one master class). Those registering by August 25, 2011 will receive a $300 discount and those registering by September 22, 2011 will receive a $200 discount. In addition, 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 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.