Anne Walsh is presenting at the Forum on Fraud and Abuse in the Sales and Marketing of Medical Devices

AKW Chairperson and 3/11 Co-Presenter: Understanding and Adapting to New Guidance Regarding the Parameters of Conversation and Dissemination of Information Regarding Off-Label Use of Medical Devices."


March 12, 2015

Program Description

Whether you are a regulator, litigator, compliance specialist or consultant, it is critical to stay current on 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 issuing 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 and regulation 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 Second Annual Eric M. Blumberg Memorial Lecture and case studies of litigation strategies presented by attorneys who handled the actual cases.

Who Should Attend?

• Attorneys and litigators at all experience levels

• Regulators

• Compliance experts

• Consultants, primarily in the drug, medical devices, biologics, and food and dietary supplements industries

• Academics