miércoles, 1 de marzo de 2017

FDA Law Blog: ACI’s 29th FDA Boot Camp

FDA Law Blog: ACI’s 29th FDA Boot Camp





Posted: 28 Feb 2017 04:28 PM PST
The American Conference Institute’s (“ACI”) popular FDA Boot Camp, now in its 29th iteration, is back in New York at the Millennium Broadway Hotel on March 22-24, 2017. 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.  Back by popular demand, this year’s “Ripped from the Headlines” session that will provide you with updates on the key developments in the FDA regulatory bar, including post-election developments and the impact of the new administration on FDA practice.

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 head one of leading workshops on the program: “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.