Enforcement Conference-Weather Advisory
The Enforcement, Litigation and Compliance conference will proceed tomorrow as planned. However, if the predicted snowfall overnight becomes a reality, we will follow this contingency plan based on the Federal Government operating status, found here: http://www.opm.gov/
- If the Federal Government is CLOSED, we will begin one hour late at 9:45AM
- If the Federal Government is OPEN under delayed arrival, we will begin one hour late at 9:45AM
- If the Federal Government is OPEN or open with the option of telework or unscheduled leave, we will begin on time at 8:45AM
Whether you are a regulator, litigator, compliance specialist or consultant, it is critical to keep up with the changing trends in enforcement, litigation, and compliance. Across all agency-regulated products, the Food and Drug Administration (FDA) is expected to continue its heightened enforcement efforts. The Department of Justice and States’ Attorney General offices are becoming increasingly active in securing Consent Decrees and Corporate Integrity Agreements. Public advocacy groups are voicing their concerns that compliance is a top priority.
This two-day conference will thoroughly examine the changes in law, regulation and practice in the last year and predict changes in the year ahead. Attendees will hear from top regulatory agency officials, including Office of Compliance directors invited from all six product Centers at FDA, the Department of Justice, HHS Office of the Inspector General (OIG), industry and the private bar.
The conference will feature the Inaugural Eric M. Blumberg Memorial Lecture (in honor of the long-time FDA attorney who passed away earlier this year) and case studies of litigation strategies presented by attorneys who handled the actual cases.