Top Government Regulators to Address Fraud & Abuse Enforcement Priorities
The federal and state governments are actively investigating allegations of off-label, False Claims Act, anti-kickback, and Park Doctrine violations, as they tell you about their upcoming enforcement priorities. It is imperative for you to understand what activities trigger increased scrutiny and how a government investigation begins. At this event, learn what the government is currently focusing on as top government officials who are actively involved in the pursuit of fraud and abuse cases share their priorities including: Eric Blumberg, Deputy Chief Counsel for Litigation, FDA; Alex Kriegsman, Assistant U.S. Attorney and Health Care Fraud Coordinator, New Jersey; Robert O’Neill, U.S. Attorney, Florida; Viveca Parker, Assistant U.S. Attorney, Pennsylvania;
Huge Dollar Settlements Not Enough to Curb Fraudulent Behavior – Individual Indictments Will Be on the Rise
In September 2010, the FDA stated its intent to more closely pursue executives in their individual capacity within the pharmaceutical company. By November 2010, the DOJ indicted a high-level executive from a major pharmaceutical company for her activities related to the sales and marketing of drugs. It is essential now more than ever for you to establish strong compliance programs to detect and remediate any fraud or misconduct that could otherwise form the basis for these indictments. Learn from in-house executives at Abbott, Gilead Sciences, and Medicis Pharmaceuticals on how to insulate yourselves from liability under the Park Doctrine and avoid violating the FDCA.
Additionally, benchmark your compliance practices against executives from: Allergan, Astellas US, Bausch & Lomb, Eisai, Inc., Eli Lilly and Company, EMD Serono, GlaxoSmithKline, InterMune, Mylan, Inc., Otsuka America Pharmaceutical, Novartis, Pfizer, and Talecris Biotherapeutics.
As Pharmaceutical Operations Become More Global, So Do the Global Compliance Risks
In the last year, several pharmaceutical companies received notice that they were under investigation to determine if they made improper payments to foreign physicians and health officials in various countries. DOJ has indicated its intent to enforce FCPA as it relates to pharmaceutical companies. As companies expand their global reach, it is crucial that you learn how to build a global compliance program that withstand the scrutiny of multiple countries.
Add Conference Value As You Drill Down Into the Nuances of Off-Label Promotion
New this year, ACI will be offering an Advanced Focus on Off-Label Communications, a day of sessions dedicated exclusively to your most pressing challenges in off-label promotion. Topics of discussion include: defining off-label communications, preparing for an investigation, developing a global compliance program, and institute best practices to mitigate the risks of promoting your product off-label. Attend this one-day session to tackle the challenges associated with drug promotion and manage off-label risks with confidence.
Register now to ensure your place at this industry leading event. Call 1-888-224-2480, fax your registration form to 1-877-927-1563, or register online
Read more about this at http://www.americanconference.com/
# # #
A unique organization, American Conference Institute is devoted to providing the business intelligence that senior decision-makers need to respond to challenges both here in the US, and around the world.
