American Conference Institute's (ACI) FDA Boot Camp

Partner Judith Waltz is speaking at the American Conference Institute’s (ACI) FDA Boot Camp May 29 – 30, 2008 in San Francisco, California.

Ms. Waltz is speaking on May 29, 2008 at 3:10 p.m. with Paul T. Kim, Partner at Foley Hoag LLP; Ioana Petrou, Criminal Health Care Fraud Coordinator at the US Attorney’s Office, NDCA; and James H. Smith, Associate Chief Counsel at the U.S. Food and Drug Administration. The panel will be moderated by Bret Koplow, Partner at Patton Boggs LLP.

Their session is titled “From Theory to Practice: FDAAA, Future FDA and Legislative Priorities, Other Enforcement Initiatives, and Beyond.” Topics to be covered include:

• FDAAA – how companies must now adapt
  • implementation considerations
  • avoiding civil penalties and fines for noncompliance
• Overriding philosophy, goals, and priorities of the FDA at this juncture and what to expect to be high on the agency’s agenda
• What now sparks an FDA investigation?
• Steps to take after receiving warning letters
• Consent decrees: what you now must know
• Other significant recently enacted and proposed legislation and their food and drug implications
  • Sunshine Acts and other bills requiring additional disclosures and greater transparency
  • proposed amendments to the Federal False Claims Act
  • analysis of increased legislative activity at the state level
  • developing methods for tracking and complying with diverse requirements
• When will DOJ prosecute?
• Understanding government enforcement tools and procedures
• Current enforcement priorities as evidenced by recent investigations
• Identifying conduct that can trigger government scrutiny
• How recent large settlements should be reflected in risk mitigation strategies