American Conference Institute (ACI) will be holding the next session of it FDA Boot Camp conference on September 13-15 in Boston, MA. ACI faculty will help attendees:
• Master the basics of the application and approval processes for drugs, biologics, and devices;
• Comprehend the intricacies of expedited approval, combination products, and companion diagnostics;
• Develop a practical working knowledge of clinical trials for drugs and biologics;
• Learn about labeling and how it serves as the transition between the approval process and the post-approval world;
• Appreciate the complexities of pharmaceutical and biologic IP and the regulatory balance between brand name and generic products;
• Analyze the emerging trends and how new legislation might impact FDA practice;
• See the importance of cGMPs to the post-approval regulatory process;
• Navigate off-label and new uses for drug products; and
• Understand the impact of adverse events monitoring, signal detection, and product withdrawals.
In particular, ACI's faculty will offer presentations on the following topics:
• Navigating the Approval Process for Drugs and Biologics;
• Expedited Approval Process and Unique Considerations in the Approval of Combination Products and Companion Diagnostics;
• Understanding the Clinical Trial Process for Drugs and Biologics
• Drugs and Biologics: Labeling;
• Patents, Trademarks, and Other IP Protections and Mechanisms;
• Hatch-Waxman and BPCIA Overview;
• Breaking News, Cases, Emerging Trends, and New Legislation Likely to Impact FDA Practice;
• Threading the Needle: Navigating Off-Label/New Use;
• Examining Current Good Manufacturing Practices and FDA's Authority and Procedure Regarding Recalls;
• Adverse Events Monitoring, Pharmacovigilance and Risk Management.
In addition, two pre-conference workshops will be offered on the afternoon of September 13, 2017, from 1:00 pm to 4:15 pm and 4:30 to 5:30, respectively. The first workshop is entitled "FDA Fundamentals and What to Expect During a Sponsor Meeting with the FDA," and the second workshop is entitled "Ethics: Ethical Considerations Relevent to the Communications with the FDA." One post-conference workshop on "Hatch-Waxman and BPCIA in the Trenches: Deconstructing and Constructing an Exclusivity Dispute" will be offered on September 15, 2017 from 1:30 to 4:30 pm.
An agenda for the conference and information regarding the workshops 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), $3,395 (conference and all three workshop). Patent Docs readers are entitled to a 10% discount off of registration using discount code P10-999-PTD18. Those interested in registering for the conference can do so here, by e-mailing [email protected], or by calling 1-888-224-2480.
Patent Docs is a media partner of ACI's FDA Boot Camp.
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