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Audio conference highlights

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.

This audio conference covers:

• FCPA requirements and prohibitions
• Recent enforcement and case studies
• How to conduct a risk assessment
• Compliance strategies for mergers and acquisitions
• Compliance strategies for daily operations
• Minimizing the impact of an enforcement action

About the speakers:

Bethany Hills practices in the Life Sciences Group at Hodgson Russ LLP, focusing her efforts on assisting life science companies with regulatory and compliance matters. She represents these companies in all aspects of their business, from regulatory submissions such as NDAs, 510(k)s, or PMAs, to collaborative agreements for research, supply and distribution, or joint product development. Ms. Gilbert combines her health law experience in third-party, Medicare, and Medicaid reimbursement with her life science experience to assist manufacturers and distributors with issues relating to pricing, coding, labeling, advertising, and FDA enforcement. She has assisted clients in responding effectively to FDA enforcement actions, including product liability, recalls, seizures, FDA warning letters, and other notices of alleged violation. She also assists FDA-regulated industries with both domestic and foreign regulatory compliance, including import and export issues.

Michelle Merola works within the Business Litigation Practice Group at Hodgson Russ LLP. She defends corporations and individuals in all aspects of criminal and regulatory investigations, including those premised on allegations of fraud, false claims, tax evasion, money laundering, customs violations and environmental offenses. Recently, her practice has focused on representing health care and life science companies in government enforcement actions and advising them on related compliance matters. She has combined her criminal enforcement experience with her regulatory knowledge to assist medical device, biologic and food manufacturing companies facing an array of government audits and investigations, including fraud and abuse investigations and FDA inspections. Prior to joining the firm, Ms. Merola served as an Assistant United States Attorney for the District of Columbia, where she oversaw and directed fraud investigations involving a variety of government agencies, including the Federal Bureau of Investigation, the Department of Treasury, the Secret Service, the Department of Transportation, and the District of Columbia Tax and Revenue Office.

Who should attend?

• In-house Counsel
• Regulatory Affairs
• Compliance Officers
• Business Development
• Marketing
• Senior Management
• Outside Counsel involved with compliance or mergers and acquisitions

*Please note: Each registration covers one line connected to the audio conference. Attendees dialing from separate locations are required to have separate registrations.