The American Conference Institute’s (“ACI’s”) “FDA Boot Camp: Drugs & Biologics Edition” – now in its 30th iteration – is scheduled to take place from September 13-15, 2017, at the Omni Parker House, in Boston, Massachusetts. 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 will provide you not only with the essential background in FDA regulatory law to help you in your practice, but also key sessions that show you how this regulatory knowledge can be applied to situations you encounter in real life. A distinguished 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 and biologics, including: INDs, NDAs, BLAs, OTC Approval, the PMA process and the Expedited Approval Process
Clinical trials for drugs and biologics
Unique Considerations in the approval of combination products, companion diagnostics, and stem cell therapies
The role of the Hatch-Waxman Amendments in the patenting of drugs and biologics
Labeling in the drug and biologics approval process
Off-Label use and a New World Order
cGMPs, adverse events monitoring, risk management and recalls
Hyman, Phelps & McNamara, P.C.’s Kurt R. Karst, 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 lead a conference workshop, titled “Hatch-Waxman and BPCIA in the Trenches: Deconstructing and Constructing an Exclusivity Dispute.” During the workshop, Mr. Karst will deconstruct, in a step-by-step manner, a complex exclusivity dispute, analyzing the various (and sometimes evolving) positions on exclusivity presented. 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 10% 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.