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Past Event
17-18 September 2013
Omni Parker House
Boston, MA


  • Joseph A. Mahoney
    T +1 312 701 8979

FDA Boot Camp: In Depth Hatch-Waxman, BPCIA, and Post-Approval Concerns

Basic training in core regulatory concepts for life sciences lawyers

Preeminent members of the nation’s Food and Drug bar will drill you in the basics of FDA law and regulation as they help you:

  • MASTER the basics of the application and approval processes for drugs, biologics and devices
  • COMPREHEND the structure of the FDA and the roles of the three major agency centers: CDER, CBER, and CDRH
  • DEVELOP a practical working knowledge of clinical trials for drugs and biologics and the clearance process for devices
  • LEARN how devices are classified, monitored, and regulated
  • APPRECIATE the complexities of pharmaceutical IP and the regulatory balance between brand name and generic products
  • RECOGNIZE the pivotal role of labeling in the drug and biologics approval process
  • SEE the importance of cGMPs to the post-approval regulatory process
  • NAVIGATE the protocols of adverse events monitoring, signal detection, product withdrawals, and recalls

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