HCM Marketplace

WEBCAST ON CD

Sponsored by Compliance e-learning training

presented on September 18, 2007

The stakes are higher than ever with more than 150 ongoing drug and device investigations. It is crucial that your sales representatives and other members of your organization recognize potential red flags and implement proper sales procedures to avoid settlements from false or misleading information.

With the government’s increased focus on off-label promotion, manufacturers must be proactive in identifying and managing potential risk areas. Listen to ePharmaceuticals for Off-Label Sales: Identify and manage your top ten risk areas, a 90-minute Webcast for tools and strategies to help you assess and measure your company’s risk exposure. Two legal experts identify the top 10 high-risk areas for off-label sales. They also discuss ways of developing risk assessments and procedures to audit and monitor your key exposure points, thus minimizing liability from federal and state agencies.

At the conclusion of this Webcast, participants will be able to:

• Identify at least five potential solutions to manage off- label compliance risks
• Analyze and learn from the recent Purdue settlement
• Define the key focus areas of both government investigations and private plaintiff allegations regarding off-label sales and apply these focus areas to develop a framework to manage risk
• Identify the top 10 areas of off-label sales risks

Agenda

• Lessons learned
  • Most recent pharmaceutical settlements involving allegations of off-label sales and promotions
  • Off-label promotion implications for private product liability lawsuits
• Top 10 areas of off-label sales risks: Legal and operational analysis
  • Discussions with field sales and medical affairs personnel
  • Responses to unsolicited medical requests
  • Thought leadership from key opinion leaders
  • Peer reviewed journal articles
  • Medical education
  • Advisory boards
  • Consultant meetings
  • Peer-to-peer discussions
  • Promotional speaker programs
  • Scientific meetings
• Other risk areas to examine
  • Physician call plans
  • Marketing documents
  • Foreign documents
• How to conduct a risk assessment to measure your company's exposure
  • Assess each brand for potential risks
  • Review of brand plans and marketing documents
  • Review of grants and charitable contributions
  • Communication protocols and use of detailing aids
  • Service agreements with healthcare professionals for activities such as advisory boards, speaker programs, and consultant meetings
  • Third party vendors such as marketing and meeting planning agencies
• Tools to audit and monitor key exposure points to minimize enforcement risk
  • How to conduct speaker program audits
  • How to audit and monitor the activities of third-party vendors
  • Conducting verbatim audits of the sales force
  • Utilizing syndicated data sources to track off-label sales
• Additional considerations for off-label uses: Pre-approval discussions with key opinion leaders
• Q &A

Meet the Speakers

Stephen J. McConnell is a partner in the mass torts and product liability group with Dechert LLP in Philadelphia. He served as an Assistant United States Attorney in the Central District of California (Los Angeles), where he investigated and prosecuted criminal cases in the Major Frauds Section. Stephen has first-chair experience in both government and private practice cases, and has successfully argued significant matters before federal and state trial and appellate courts.

Debjit A. Ghosh, is a Director for Huron Consulting Group’s Pharmaceutical and Medical Device Industry Team. Debjit currently assists pharmaceutical, medical device, and biotechnology clients on a wide range of matters including compliance, litigation support, operational consulting, valuation, and pricing.  He has provided expert testimony on issues related to off-label promotions, government price reporting, determination of fair market value, and commercial contracting.

Who Should Attend this Webcast?

Pharmaceutical and Biotech professionals in the following fields:

• Legal
• Compliance Officers
• Regulatory and legal officers
• In-house counsel
• Risk management
• Marketing and sales leadership
  

Webcast Program Materials

You will receive presentation slides, and other materials that you can print and distribute to all of your peers at your location.

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

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