American Conference Institute (ACI) will be holding the next session of its FDA Boot Camp conference on March 10-11, 2015 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:
• Brief Overview of FDA Practice
• The Nature of the Approval Process
• Understanding the Clinical Trial Process for Drugs and Biologics
• Drugs and Biologics: Labeling
• 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
• The Drug Supply Chain Security Act -- Summarizing the Act and Its Effect on FDA Practice
• cGMPs: Drugs and Biologics (Current Good Manufacturing Practices)
• Medical Devices: Classifications, the Essentials of the Premarket Review Process, and Post-Market Requirements and Concerns
• Using FDA's Citizen Petition Process and Litigation to Achieve Market Success
• How to Respond to FDA: Best Practices, Tips, Tricks, and Pitfalls to Avoid
• Adverse Events Monitoring, Pharmacovigilance and Risk Management, and Recalls
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 9, 2015 from 1:00 to 5:00 pm. Two post-conference master classes will be offered on March 11, 2015. The first master class is entitled "Hatch-Waxman and BPCIA: Overview of Biosimilars and Life Cycle Planning for Drugs and Biologics," and the second master class is entitled "Post-Approval Marketing Guidance and Preemption Protocols."
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 or one master class), or $3,495 (conference, workshop, and one master class). 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 conference.
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