HCM Marketplace

AUDIOCONFERENCE ON TAPE OR CD

Brought to you by Briefings on Part D Compliance

presented on AUGUST 8, 2006

Legal and government surveillance of CME and traditional medical education are intensifying, so how do you keep med ed fresh, effective and creative yet compliant? How do changing ACCME guidelines affect your approach? This program will open your eyes, sharing what's new and what's coming on the legal/regulatory front and help listeners prepare — including product managers, medical affairs, legal and marketing.

AGENDA

I. CME Legal Developments
     A. What's new? (cases, regulatory action, lessons learned analysis)
     B. What's coming?
     C. How to prepare?
     D. OIG, FDA and other regulatory developments
     E. Practical recommendations for improving internal controls as surveillance heats up

II. Role of CME vs. Traditional Medical Education
     A. What's more beneficial to the marketer and why?
     B. Marketing/Sales "hands-off" policy for CME
     C. CME as "value-added" service for physicians

III. Is CME worth it? If so, how can Medical Affairs/Education improve their internal process to produce a more effective, compliant CME strategy
     A. Professional Education director shares experiences and recommendations
     B. Strategies to improve the brand team and medical affairs relationship
     C. Regulatory Compliance considerations
     D. Stakeholder communication
     E. Negotiating spending for CME: A successful approach

IV. Grey Area Scenarios/Panel Discussion
   A. Scenarios
           1..Physicians scared about serving as CME faculty
           2. Reps playing a role in selecting faculty
           3. Off-label issues
           4. Manufacturers using CME to promote in disease categories they shouldn’t be
     B. Analysis with responses from the ACCME, marketing, and legal perspectives

Q & A

SPEAKERS

Barbara A. Fuchs, MSA, is an Associate Director in Professional Education Support at Wyeth Pharmaceuticals. She has many years of experience as a healthcare professional, holding key clinical and administrative positions in healthcare organizations including managed care. Prior to joining Wyeth, she served as the Executive Director of a for-profit Continuing Medical Education company. This has given her a unique perspective on the regulations governing CME as well as the grant process. Barbara is an adjunct professor in the Nursing program at Eastern University, a Certified Professional in Healthcare Quality and is a frequent faculty member at the Annual Meeting of the Alliance for Continuing Medical Education.

John DeHart, is a Managing Partner at CMEsolutions, LLC located in Tucson, AZ. In 1978, John joined Bayer with the Biological Products Division. John's career with Bayer represented almost 20 years in the sales, marketing, and management of biological and pharmaceutical products. Before leaving Bayer in 1996, he was responsible for the coordination and management of all immunological products worldwide, establishing both tactical and strategic objectives, with full budget responsibilities. He left Bayer to co-found CMEsolutions. John has a B.S. degree from Weber Sate University in Accounting, Finance and Marketing.

Keith Korenchuk, is a Partner at McGuire Woods LLP located in Washington D.C. Keith counsels and advises pharmaceutical, life sciences, medical device and specialty pharmacy companies in the United States and around the world. The focus of his work is on regulatory and compliance challenges confronting these sectors under federal, state and international laws. He provides guidance and assistance on matters ranging from design and implementation of compliance systems, specific product launch, sales/marketing and compliance issues, internal and government investigations, and negotiation and implementation of strategic relationships to enable companies to achieve their business objectives in a complex operating and regulatory environment.

Christopher King, is a Managing Partner at CMEsolutions, LLC. Chris has over 30 years of experience in developing products and markets in the pharmaceutical/biotech industry. Since 1997, Chris has been Managing Partner of CMEsolutions. Chris began his career in the health care industry when he joined Pfizer, Inc (1975) and Bayer (1983) where he gained a broad range of industry experience in a series of sales, marketing, and management positions in several therapeutic categories.

WHO SHOULD LISTEN?

This is a great chance to bring together medical education with other key departments.

• Pharmaceutical and bio industry professionals
• CME Companies
• Product Managers
• Medical Affairs
• Marketing
• Medical Education
• Professional Education
• Sales
• Physicians
• Legal Affairs
• Regulatory Affairs
• Compliance

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 will be provided with PDF links.

• Audioconferences

• Other Life Sciences Products