• 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.
• 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);
• Adverse events monitoring, pharmacovigilance and risk management;
• Medical devices: Classifications, the essentials of the premarket review process, and post-market requirements and concerns; 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 September 19, 2012 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 September 21, 2012. 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 July 27, 2012 will receive a $300 discount and those registering by September 5, 2012 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 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.