A Noteworthy Event for the Drug and Device Industries

August 15, 2008

Robert A. Dormer of Hyman, Phelps & McNamara, P.C. will be speaking at American Conference Institute’s FDA Boot Camp conference, September 22-23, 2008 at the Sheraton Boston Hotel in Boston, MA. Click here for a copy of the agenda.

At the event, preeminent members of the nation’s Food and Drug bar will

drill products liability and IP/patent lawyers in the basics of current FDA law and regulation — including the nuances of the FDA Amendments Act. They will help you:

  • MASTER the basics of the application and approval processes for drugs, biologics, and devices
  • DEVELOP a practical working knowledge of clinical trials for drugs and biologics and the clearance process for devices
  • APPRECIATE the regulatory balance between brand name and generic products
  • UNDERSTAND the complexities of the patent and IP landscape, including Hatch-Waxman, Orange Book, 180-day exclusivity, 30-month stay, Paragraph IV, NDA, ANDA and 505(b)(2)
  • RECOGNIZE the role of labeling in the drug/biological product approval process
  • SEE the importance of cGMPs to the post-approval regulatory process
  • NAVIGATE the protocols of adverse events monitoring, pharmacovigilance, and Risk Evaluation and Minimization Strategies (REMS)
  • LEARN how devices are classified, monitored, and regulated
  • EXPLORE FDA’s expectations and guidance for recalls

Additional details and registration information are available at the American Conference Institute’s website or by calling 888-224-2480. If you register by or before August 29th, you can lock in the lowest rate.

Categories: Miscellaneous