Enforcement, Litigation and Compliance Conference


December 12-13, 2012 | The Westin Georgetown | Washington, DC



General Information

Save the Dates for 2013
December 10-11

 

Who Should Attend?

This conference is designed for attorneys and litigators of all experience levels, regulators, compliance experts, consultants and academics in primarily the drug, medical devices, biologics, food and dietary supplements industries. The conference will also touch on tobacco, vet med, and cosmetic industry issues. 


Audience: 

Food, Drugs, Medical Devices, Animal Drugs, Biologics, Cosmetics, Diagnostics, Dietary Supplements, Tobacco

Level: 

Introductory/Intermediate/Advanced


Purchase the Conference CD

$199 Members
$299 Non-Members



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, building from its mid-2011 internal structural reorganization and its new regulatory authority granted through provisions under the Food and Drug Administration Safety and Innovation Act (FDASIA).  The Department of Justice and States’ Attorney General offices have followed--and will follow--suit, issuing Consent Decrees and Corporate Integrity Agreements.  Public interest groups have also become more vocal, sending the message to industry that safety and compliance is a serious priority. 

This two-day conference thoroughly examined the changes in law and regulation in 2012 and analyzed trends and changes in the year ahead.  This annual conference is unique in its scope — covering all FDA-regulated areas, allowing attendees to benefit from a birds-eye view of compliance trends across industries.

Attendees heard from top regulatory agency officials, including Office of Compliance directors from all six centers at FDA, the Department of Justice, HHS Office of the Inspector General (OIG), industry and the private bar who:

  • Identified developments in compliance.
  • Provided an understanding of administrative remedies and collateral damage by outlining OIG debarment policies and practices and False Claims Act (FCA) developments.
  • Analyzed important recent cases and identified the decisions made to settle or litigate.
  • Highlighted global enforcement mechanisms after the Food Safety and Modernization Act (FSMA) and FDASIA.