The ABCs of FDA: Regulatory, Fraud and Abuse Issues

More and more companies are venturing into medical devices, drugs or biologics in an effort to diversify or to promote new biotechnologies. At the same time, the United States government is taking a more active role in regulating the manufacturers, providers and payers in the healthcare industry. The collision of these two trends – increased interest in marketing healthcare products along with increased government involvement in regulation and enforcement – require companies to attain FDA regulatory compliance and prevent fraud and abuse violations in order to be successful in this industry and avoid multi-million dollar fines and penalties.

In this audio conference, the speaker addresses the basic things that people and companies need to know about dealing with the FDA and succeeding in the life sciences industry.

The ABCs of FDA: Regulatory, Fraud and Abuse Issues was presented by Bethany Gilbert, with Hodgson Russ LLP and aired on 2008-05-15. For more details, or to download this event please visit our site at www.fxconferences.com

FCPA Compliance Strategies for Medical Device & Pharma Companies

The Foreign Corrupt Practices Act (FCPA) has had a major impact on the way companies conduct business abroad. A U.S. anti-corruption law jointly enforced by the Department of Justice and the Securities and Exchange Commission, its main provisions deal with improper payments to foreign officials and questionable accounting practices used to hide them. Violating the FCPA can result in both criminal and civil penalties, and the requirements are complex, applying to both companies in the U.S. and foreign-based companies subject to U.S. securities laws. Past enforcement actions have crossed industry boundaries and included the pharmaceutical industry. Lately, there has been an increase in FCPA enforcement activity in the medical device industry as well.

In this audio conference, our speakers combine their experience with real-world case studies to provide a clear background on the FCPA requirements and enforcement trends, along with practical compliance strategies to keep device and pharma companies from running afoul of the law.

FCPA Compliance Strategies for Medical Device & Pharma Companies is being presented by Bethany Hills & Michelle Merola, with Hodgson Russ LLP and airs Wednesday, April 1, 2009. For more details or to register for this event, please visit our site www.fxconferences.com

The Foreign Corrupt Practices Act: Compliance Strategies

The Foreign Corrupt Practices Act (FCPA) is a U.S. anti-corruption law jointly enforced by the Department of Justice and the Securities and Exchange Commission. Its main provisions deal with improper payments to foreign offficials and questionable accounting practices to cover up these sorts of transactions. Violating FCPA requirements can result in criminal and civil penalties, and the law has had a major impact on the way companies conduct business abroad. The requirements of the FCPA are complex and apply to both companies in the U.S. and foreign-based companies subject to U.S. securities laws. Past enforcement actions have crossed industry boundaries and included the oil industry, telecommunications and pharmaceuticals. Recently, an increase in FCPA enforcement activity in the medical device industry has caught the attention of CEOs, CFOs, and Marketing and Sales executives.

In this audio conference, our speakers will combine their experience with real-world case studies to provide a clear background on the FCPA requirements and enforcement trends, along with practical compliance strategies to avoid prosecution.

The Foreign Corrupt Practices Act: Compliance Strategies is presented by Bethany Gilbert & Michelle Merola, of Hodgson Russ LLP. For more details please visit our site www.fxconferences.com