American Conference Institute (ACI) will be holding the next session of its FDA Boot Camp conference on September 30 to October 1, 2015 in Boston, MA. 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
• Using FDA's Citizen Petition Process and Litigation to Achieve Market Success
• cGMPs: Drugs and Biologics (Current Good Manufacturing Practices)
• The Drug Supply Chain Security Act -- Summarizing the Act and Its Effect on FDA Practice
• Medical Devices: Classifications, the Essentials of the Premarket Review Process, and Post-Market Requirements and Concerns
• 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 September 29, 2015 from 1:00 to 5:00 pm. Two post-conference master classes will be offered on October 1, 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 $2,195 (conference alone), $2,795 (conference and workshop or conference or one master class), or $3,095 (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.
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