ACI’s 28th FDA Boot Camp

The American Conference Institute’s (“ACI”) popular FDA Boot Camp, now in its 28th iteration, is slated to take place at the Omni Parker House in Boston, Massachusetts from September 22-23, 2016. The conference is billed as the premier event to provide folks with a roadmap to navigate the difficult terrain of FDA regulatory law.

This year’s FDA Boot Camp has been designed to not only provide attendees with the essential background in FDA regulatory law, but also to provide key sessions that show attendees how to apply the regulatory knowledge to situations encountered in real life. Highlights of this year’s program include the “Ripped from the Headlines” sessions that will update attendees on key developments in the FDA regulatory bar, and “The Marketing Pendulum Has Swung,” which will focus on case studies analyzing off-label civil and criminal enforcement activity.

A stellar cast of presenters will share their knowledge and provide critical insights on a host of topics, including:

• The organization, jurisdiction, functions, and operations of FDA
• The essentials of the approval process for drugs, biologics, and devices, including: INDs, NDAs, BLAs, OTC Approval, 510(k) submissions, and the PMA process
• Clinical trials for drugs and biologics and the clearance process for devices
• The classification of devices and the concept of “risk-based” classification
• The role of the Hatch-Waxman Amendments in the patenting of drugs and biologics
• Labeling in the drug and biologics approval process
• cGMPs and other manufacturing concerns relative to products liability
• Proactive adverse events monitoring and signal detection
• Recalls, product withdrawals, and FDA oversight authority

Hyman, Phelps & McNamara, P.C.’s Kurt R. Karst, who is co-chairing the conference, will present with a panel of experts and provide an overview of the Hatch-Waxman Amendments and the Biologic Price Competition and Innovation Act (“BPCIA”).  Mr. Karst will also head one of the workshops new to the ACI FDA Boot Camp program. Titled “Hatch-Waxman and BPCIA in the Trenches: Deconstructing and Constructing an Exclusivity Dispute,” Mr. Karst will deconstruct, in a step-by-step manner, a complex exclusivity dispute, analyzing FDA’s and the disputing parties’ various (and sometimes evolving) positions on exclusivity.  Relevant court decisions will also be analyzed and their practical and future effects discussed.  After the exclusivity case analysis is completed, attendees will have the opportunity to construct their own exclusivity dispute by choosing from various base facts.  Once the case is constructed, Mr. Karst will lead attendees through the exclusivity analysis. 

FDA Law Blog is a conference media partner. As such, we can offer our readers a special 15% discount. The discount code is: P10-999-FDAB17. You can access the conference brochure and sign up for the event here.  We look forward to seeing you at the conference.