January 27-28: CBI Pharmaceutical Compliance Congress in Washington, D.C.; February 11-12: CBI Compliance Congress for Medical Device and Diagnostics in Chicago

 

CBI’s 2015 Pharmaceutical Compliance Congress (PCC) will take place on January 27-28, 2015 at the Ritz Carlton in Washington, D.C. 

The Conference is in its 12th year, and continues to provide an impressive list of speakers covering a wide spectrum of important compliance issues. The full agenda is available here. 

Enforcement Perspectives

*U.S. Healthcare Fraud Enforcement Panel —Trends and Top Priorities, featuring U.S. attorneys from several districts

*Office of Prescription Drug Promotion, Update on Enforcement, Policy and Oversight Trends, Thomas Abrams, Director, OPDP, FDA

*FDA Address on Compliance and Enforcement Activities, Howard Sklamberg, Deputy Commissioner for Global Regulatory Operations and Policy, FDA

*SEC Address – FCPA, Disclosure and Internal Controls Issues in the Pharmaceutical Industry, Andrew Ceresney, Director of Enforcement, SEC

*Department of Justice Address: Intellectual Property and Counterfitting–Enforcement and Areas of Focus, John H. Zacharia, Assistant Deputy Chief for Litigation, DOJ

Other highlights

*FCPA session: Combating Bribery and Corruption Through Information Intelligence — Putting Your Data to Work

*Defense Panel: A View from the Outside — Mitigating Risk and Preparing for the Future

*Chief Compliance Officer Panel

*Specialized workshops on a variety of compliance topics, including Sunshine, promotion, off-label discussion, and international issues. 

 

 

CBI’s 2015 Compliance Congress for Medical Device and Diagnostics will take place on February 11-12, 2015 at the Sheraton Hotel &Towers in Chicago.  

The med device oriented conference features an enforcement panel with several Department of Justice Attorneys. Prosecutions involving device companies for kickback and pricing violations, off-label marketing, and labeling continue to pose challenges for ongoing compliance, and the panel will provide information regarding recent developments. Topics include discussion of recent case settlements and prosecutions, insights into top priorities, and emerging areas of focus. 

This conference also will have industry sessions with speakers from Biomet, Endologix, Fresenius Kabi, Johnson & Johnson, Karl Storz, the Medical Device Manufacturers Association, Medline Industries, Siemens, Spectranetics, and Wright Medical. Maria Sainz, President and CEO of Cardiokinetix, Inc., will give the keynote address. 

There are numerous interesting topics on the agenda, including Open Payments sessions, risk-mitigation sessions both nationally and globally, as well as how to manage a compliance department within a small device company.

View the full agenda and website here.