HCM Marketplace

WEBCAST ON CD

Sponsored by Compliance Training Handbook for Pharmaceutical Reps
presented on December 12, 2007

Speaker programs are a valuable tool to educate providers and key opinion leaders about a product…but they pose certain risks. A mistake in speaker compensation or field-level activities could open your compliance program to a broader investigation.  The OIG has made pharma speaker programs a priority, and you and your marketing department need to work together to remain in compliance with speaker program policies.

Listen to ePharmaceticals for the 90-minute Webcast “Pharmaceutical Speaker Programs: Real-world strategies to prevent litigation.”  Healthcare compliance attorney Daniel Kracov, JD of Arnold & Porter, LLP will discuss recent legal trends in pharmaceutical speaker programs and provide insight into the direction of government focus. He will also offer his observations on strategies your company can employ to lawfully avoid OIG scrutiny. Jane Wright-Mitchell, PharmD, JD (Vice President of Legal Affairs for Actelion Pharmaceuticals) will discuss how her organization implemented a successful speaker program, offering a behind-the-scenes case study on how the program was built, as well lessons learned from the process.

At the end of this Webcast, you will be able to:

• Recognize actions that will draw federal scrutiny to your speaker program
• Identify steps to implement a compliant speaker program
• Illustrate, through a case study, how a company has successfully built a new speaker program
• Recognize how legal and compliance can work internally with commercial/marketing for compliant speaker program policies
• Identify how to handle difficult situations involving compensation,, fair market value, and day-to-day speaker program issues

AGENDA

• Current issues
• Government focus
• Developments over the past year
• How to monitor your program based on recent enforcement actions
• Case study - Actelion Pharmaceuticals’ Speaker Program Policy
  • Policy development
  • Policy details
  • Training
  • Monitoring to assure speaker adherence
• Case study- Lessons learned
• Formal auditing of the speaker program policy
• Structured and formal speaker training
• Developing slide sets for speakers
• Pitfalls
• Situations/gray areas that are problematic and how to deal with them
  Each situation will include an example from the field, the legal considerations, and possible solutions
  • Addressing challenges with compensation
• How many speakers are too many?
• How do we make sure our speaker training is compliant?
• Slide set usage by speakers
• Material preparation
• When should slide sets go to DDMAC for promo review? And why?
• Appropriate speaker selection
• How to talk about risk with speakers
• What to do if your speaker talks off label and you find out
• What can your physician say about studies for unapproved drugs/indications?
• Auditing: How to proactively solve problems
• Q&A

 MEET THE SPEAKERS
Jane Wright-Mitchell, PharmD, JD, Vice President, Legal Affairs, Actelion Pharmaceuticals US, Inc.  Wright-Mitchell’s practice focuses on the areas of regulatory compliance, corporate, healthcare and litigation. She is responsible for regulatory compliance oversight, development and implementation of compliance training, grant review processing, and communications with the various federal and state agencies.  Additionally, Wright-Mitchell has primary oversight for US Commercial Operations encompassing drug access programs, government pricing and contract matters, drug reimbursement issues and coordination of all specialty distributors. 

Daniel Kracov, JD, Arnold & Porter, LLP. Kracov heads the pharmaceutical and medical device practice at Arnold & Porter, LLP. He assists clients in negotiating requirements relating to the development, approval, and marketing of drugs, biologics, and medical devices. He has handled numerous FDA and Congressional investigations, as well as legislative initiatives. He also develops regulatory corporate compliance programs and conducts regulatory due diligence investigations for financings, mergers, and acquisitions.

WHO SHOULD LISTEN?

Pharmaceutical and biotech manufacturers in these divisions and focus areas:

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

You will receive presentation slides and other materials that you can print and distribute to all of the 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.

• Webcasts

• Other Life Sciences Products