HCM Marketplace

AUDIOCONFERENCE ON TAPE OR CD

Sponsored by Pharma Compliance Alert

presented on FEBRUARY 14, 2007

"It is absolutely critical for pharma and device companies to monitor across silos for KOL management…I don't think it's possible to be too careful here….The caps and the reporting requirements apply to the company, not to its individual departments. Government authorities will likely be wholly unconcerned with internal organization when they come knocking at your door."

- - Bert Johnson, chief compliance officer, Kyphon

Are you tracking payments to healthcare providers across all departments? Failing to track aggregate spend across the organization--including sales, marketing, and R&D--could send your company into legal hot water. Hear from Edward Miller, J.D., VP, Boehringer Ingelheim Pharmaceuticals, Inc., Mark DuVal, J.D., DuVal & Associates and Welton O'Neal, Jr., Pharm.D, VP, NitroMed, to learn the correct procedures, examine the best practices, and understand the risks and benefits for a compliant, company-wide aggregate spend tracking system.

AGENDA

I. Aggregate Spend: Why you should pay attention

II. Getting your hands around this topic
A. What it is
B. How and what to monitor
C. Implications-risks/benefits

III. Nuts and bolts of how to do it
A. How are doctors paid?
B. For what are they being paid?
C. Do you consider money paid by third parties (e.g. medical education providers) to doctors and do you monitor this or not?

IV. Healthcare Providers/Key Opinion Leaders (KOLs)
A. How they are defined
B. Benefits to company
C. Conflicts of interest
D. Risks
E. R&D
  i. Commercialization of new products
F. Ongoing management
  i. Who is informed and trained?

V. Process put in place
A. Business process solution
B. Collecting and reviewing date
C. Creating a system for ongoing review and management

VI. Education and training
A. Laws, SOPs and documentation issues

VII. Open forum

Q&A

LEARNING OBJECTIVES

1. Identify issues your organization must understand to manage KOLs and aggregate spending
2. Describe the nuts and bolts ideas of what can be done to address the issue
3. Explain best practices for the management of both the internal and external KOLs

MEET OUR SPEAKERS

Edward Miller, J.D., is Vice President, Associate General Counsel and Chief Compliance Officer at Boehringer Ingelheim Pharmaceuticals, Inc. in Ridgefield, CT. In this position he manages the Boehringer Ingelheim Corporate Compliance Program and is responsible for all compliance activities, including developing and implementing compliance systems and tools, implementing compliance training, developing monitoring and auditing systems and reporting to senior management. Mr. Miller also manages the employment counseling and litigation functions for Boehringer Ingelheim Pharmaceuticals, Inc. and its affiliated U.S. companies.

Mark DuVal, J.D., is President and Managing Partner of DuVal & Associates, where he counsels pharmaceutical, medical device, biotech, food and nutritional supplement companies. He regularly advises clients in all areas of FDA law and regulation, from product development, clinical trials, inspections and recalls to reimbursement and compliance issues and post-marketing responsibilities. His specialty is in the area of counseling and training marketing, sales and MSL organizations in complying with FDA’s advertising and promotional regulations, the Anti-kickback Statute, False Claims Act, the PhRMA and AdvaMed Code’s, etc. Mr. DuVal's practice also includes combination products, specifically drugs and devices as well as biologics and devices.

Welton O'Neal, Jr., Pharm.D, joined NitroMed as Vice President Medical Affairs in August 2005. In this role, Dr. O'Neal is responsible for managing BiDil-related medical affairs, including professional services, medical education, medical compliance and awareness efforts, and the field based medical liaisons. Dr. O'Neal has extensive medical affairs experience, including fourteen years with Bristol-Myers Squibb, where he held a variety of positions with increasing responsibility in medical services, science and advocacy, culminating with his role as Vice President, Medical Advocacy and Development for the cardiovascular/metabolics division of Bristol-Myers Squibb Worldwide.

WHO SHOULD ATTEND?

Pharmaceutical manufacturers in these divisions and focus areas:

• Compliance
• Legal
• Marketing
• Speaker program directors
• Medical Affairs/MSL Directors
• Product Teams

Purchase a tape or CD of the program and listen when you can. It's a perfect training tool for new staff or as a refresher for veteran staff.

PROGRAM MATERIALS

Program materials are provided with PDF links.

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