Speaking Engagement

FDA Boot Camp: Enforcement

The American Conference Institute’s 31st FDA Boot Camp

The Park Lane Hotel
36 Central Park S
New York, NY 10019

Blank Rome Partner Joseph G. Poluka will present at the American Conference Institute’s (“ACI”) 31st FDA Boot Camp, being held Wednesday, March 7 through Friday, March 9, 2018, at the Park Lane Hotel in New York.

Joe’s session will take place Friday, March 7, from 10:00 to 10:45 a.m. His presentation will cover:

  • Enforcement overview—identifying the players and their positions
  • Investigations, enforcement, litigation, and defenses
  • Understanding potential punishments, including civil seizure, injunction, civil money penalties, and criminal prosecutions
  • FDA compliance, enforcement mechanisms, and best practices
    • Inspections
  • EIRs
  • Form FDA 483 observations
  • Untitled and Warning Letters
    • Related to inspections
    • Resulting from non-inspection data or information
  • Opioids—the new frontier?

About ACI’s FDA Boot Camp

ACI’s FDA Boot Camp is designed to provide professionals working in conjunction with pharmaceuticals, biologics, and combination products—such as patent and products litigators, in-house counsel, regulatory affairs specialists, business executives, and investors—a strong working knowledge of core FDA competencies. 

In addition to providing a “basic training,” the BRAND NEW 2018 AGENDA offers “advanced training” sessions covering the “ins and outs” of applying this knowledge to real-life situations. Highlights from this year’s program include an up-to-the minute “Ripped from the Headlines” section covering recent hot issues such as the 21st Century Cures Act, FDARA, recent actions of the new FDA Commissioner, and their impact on FDA practice.

For more information or to register, please visit the event webpage.