• 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, 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: Understanding The Connection Between FDA Regulation and IP and Related Mechanisms Under Hatch-Waxman and BPCIA
• Part 1 -- Patents, Trademarks and Other IP Protections and Mechanisms
• 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
• Recall Guidance for Drugs, Biologics, and Medical Devices: What You Need to Know
• Adverse Events Monitoring, Pharmacovigilance and Risk Management
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 11, 2014 from 1:00 to 5:00 pm. The first part of 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. The second part of the workshop will 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 13, 2014. 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, and additional information regarding the workshop and master classes 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 February 13, 2014 will receive a $200 discount. 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.