WEBCAST ON CD
Sponsored by Custom Compliance Training for Field Teams
presented on September 12, 2007
Physician advisory boards are a mixed bag proposition: they can supply remarkable clarity for your products and provide new directions and opportunities in development and marketing; yet they can also expose potential compliance risks and incur the heavy observation of regulators. T
The concept of advisory boards, while benign in theory, can lead to more questions than answers:
- How can I avoid compliance scrutiny by keeping sales messages out of my advisory board agendas?
- How can we capitalize on advisory board findings for marketing opportunities?
- What do we do if a physician mentions an adverse event during an advisory board?
- How can I create a safe honoraria schedule?
- What are hot button issues for government prosecutors?
For those responsible for scientific and physician advisory boards—including brand, customer insight, and product development teams—the challenge becomes an internal, cross-department balancing act.
Build and conduct compliant advisory boards and get the most from your programs
Listen to ePharmaceuticals for Physician Advisory Boards: Answers to your top compliance questions. This 60-minute Webcast features a former federal prosecutor, a pharmaceutical compliance expert and the associate general counsel for Enzon Pharmaceuticals. Discussion focuses on methods for conducting a fertile, compliant advisory board campaign.
The speakers cover the entire advisory board process, from the planning stages through the post-program wrap-up, and provide insight into the actual approaches effectively implemented by pharmaceutical companies. This Webcast helps you structure your advisory boards to mitigate compliance risks while maximizing the benefits to your products and bottom line.
At the end of this Webcast, you will be able to:
- Apply practical solutions from pharmaceutical company peers to manage specific advisory board compliance risks
- Work with your regulatory and marketing team to develop an effective, compliant advisory board
- Capitalize on advisory board findings from a marketing and sales perspective
- Apply or use tools provided, like a sample honoraria schedule, to update your advisory board compliance
- Understand risk areas from the government enforcement perspective
AGENDA
- Advisory board planning
- Tips for setting clear objectives
- Red flags
- Payment issues
- Need for written contracts
- How to develop an honoraria schedule
- How to justify higher honoraria
- Example of honoraria schedule
- Non monetary compensation: Other payment issues
- Compliance benchmarks
- How to determine legitimate need for advisory board
- What is too many advisory boards in a 12-month span?
- Collecting advice vs. presenting a message?
- Session length
- Number of times an individual physician should be involved
- Day of the advisory board meeting
- Company attendance
- Moderators
- Handling issues that arise during the meeting
- Post advisory board
- Example of post-meeting requirements
- Using advice from doctors
- Adverse events
- Q & A
MEET THE SPEAKERS
Tanya D. Berlage, Esq., Ms. Berlage is a partner with Saul Ewing LLP in the Life Sciences Practice Group, which represents clients in the pharmaceutical, biotech and medical device industries. Previously, she served as Vice President, Chief Counsel, North America for Taro Pharmaceuticals USA, Inc., a multinational pharmaceutical company. She worked on matters involving all stages of the pharmaceutical product life cycle, including strategic alliances, licensing, M&A, manufacturing, sales, marketing and distribution.
Christopher R. Hall, Esq., Mr. Hall is a partner with Saul Ewing LLP and is a former federal prosecutor. He represents corporations and individuals facing allegations of wrongful conduct. He assists clients during internal investigations, government criminal investigations, government civil enforcement actions, and related civil proceedings such as False Claims Act and securities fraud proceedings. Mr. Hall places particular emphasis on the heath care, financial service, defense, and government contract industries. He has tried more than 30 cases to verdict in federal courts.
Scott B. Waldman, Esq., Mr. Waldman is Senior Director and Associate General Counsel of Enzon Pharmaceuticals, Inc. He is involved in the oversight of all of Enzon's activities for its four marketed products and its pipeline of development products, including all healthcare compliance matters. Mr. Waldman also manages Enzon's licensing and business development activities, as well as general corporate matters.
WHO SHOULD LISTEN?
Professionals from both pharmaceutical and biotech companies with the following job descriptions:
- Marketing
- Brand team Product Directors
- Sales
- Compliance Officers
- Legal
- Regulatory Affairs
WEBCAST PROGRAM MATERIALS
You will receive presentation slides, and other materials that you can print and distribute to all of your peers.
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.
Save money when you purchase multiple copies! Ask your customer service representative about money-saving
discounts and bulk orders. Call toll free 800-650-6787 or e-mail
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