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National Pharma Audioconference: Examining the Latest Developments in Drug and Device CIAs How Corporate Integrity Agreements Continue to Reshape Compliance

Thursday, August 12, 2010

1:00 pm - 2:30 pm (Eastern)
12:00 pm - 1:30 pm (Central)
11:00 am - 12:30 pm (Mountain)
10:00 am - 11:30 am (Pacific)


Howard L. Dorfman, Esq.
Counsel, Ropes and Gray, Former Chief Legal Officer, Pharmaceutical Division, Bayer Healthcare LLC, Former Counsel, US Medicines Groups, Bristol-Myers Squibb, New York, NY

Wendy C. Goldstein, Esq.
Partner and Chair, Pharmaceutical Industry Health Regulatory Practice Group, Epstein Becker & Green, PC, New York, NY

Lawrence P. Platkin, Esq.
Vice President and Compliance Officer, Bayer HealthCare LLC, Wayne, NJ

Matthew Hay
Editor, Rx Compliance Report, Washington, DC (Moderator)

The Audioconference agenda is set forth in Eastern Daylight Time below:
1:00 pm Welcome and Introductions
Howard L. Dorfman, Esq.
1:05 pm Discussion of Emerging Risk Areas
Overview of CIAs and the Enforcement Landscape
  • Overview of the current enforcement landscape
  • General overview and update on recent settlements and CIAs
  • The impact of healthcare reform legislation on the industry's compliance obligations related to fraud and abuse
  • Review of other external factors impacting compliance obligations, including requirements promulgated by state legislatures, medical societies, and academic institutions
Howard L. Dorfman, Esq.
1:25 pm Key Elements of Recent CIAs and What They Mean
  • How industry obligations are evolving based on the specific requirements of recent CIAs
Wendy Goldstein, Esq.
1:45 pm An In-house Perspective
  • Analysis of what compliance organizations are required to do based on the specific requirements of a company's CIA
  • How the teachings of the CIAs that follow impact a company's existing compliance obligations
Lawrence Platkin, Esq.
2:05 pm Questions & Answers
2:30 pm Audioconference Adjournment

Sponsored by Pharmaceutical Compliance Forum
Media Partner: Harvard Health Policy Review
October 20 - 22, 2010
Washington, DC


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