COMPLIMENTARY PRE-CONFERENCE WEBINAR
Thursday, May 13, 2010 : 1 p.m. EST | 90 Minutes
(Groups are welcome to participate.CLE accreditation is only available to the primary conference registrant)
FCPA Fundamentals for Life Sciences
As government agencies aggressively continue to target the pharmaceutical and medical device industries, gain a critical and comprehensive understanding of the fundamental principles and application of the Foreign Corrupt Practices Act to life sciences companies in this 90 minute webinar course primer.
Topics include:
- FCPA’s two-pronged approach:
- Anti-bribery provision
- Books and records violations
- Who is covered by the statute?
- What constitutes a U.S. nexus?
- What activities constitute bribery under the statute?
- Third party payments
- Permissible facilitating payments
- Who is considered a public official in the life science context?
- Understanding liability for third parties and non-U.S. subsidiaries
- Affirmative defenses
POST CONFERENCE MASTER CLASS
Wednesday, May 19, 20109 a.m. – 12:00 p.m. (Registration & Breakfast 8:30 a.m.)
Conducting an Internal FCPA Investigation
Jeffrey L. Antoon
Director – Financial Internal Audit
Johnson & Johnson (New Brunswick, NJ)
Asheesh Goel
Partner
Ropes & Gray LLP (Chicago, IL; Washington, D.C.)
Bradley J. Tandy
Senior Vice President, General Counsel and Secretary
Biomet, Inc. (Warsaw, IN)
- Deciding when to conduct an investigation and developing an action plan
- Initial steps to be taken
- General investigations versus specific inquiries
- Establishing the roles and responsibilities of in-house compliance and legal teams
- Coordinating with outside consultants
- Managing effective communication
- Challenges for conducting investigations in foreign jurisdictions
- Due diligence obstacles
- Data privacy laws
- Document management
- Language barriers
- Travel
- Local laws and customs
- Special considerations for pharmaceutical and device companies
- Acquisitions of foreign subsidiaries
- Extensive global sales forces and consultants on retainer
- Contractual obligations stemming from clinical trial agreements, strategic alliances, and manufacturing relationships
- Determining what to do with the results
- Deciding when and if to prepare a voluntary disclosure
- What are the consequences of not reporting?
- When to bring in outside counsel
- Preserving privilege
Conference Details
