UNDERSTANDING OIG’S NEW COMPLIANCE PROGRAM GUIDANCE FOR PHARMACEUTICAL MANUFACTURERS – EXCLUSIVE ONE DAY SEMINAR
July 23, 2003 * The Westin Princeton at Forrestal Village, Princeton, NJ

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As a result of increased scrutiny, PhRMA issued their Code on Interactions With Healthcare Professionals in July, 2002, in an effort to assist the Pharmaceutical Industry with some much needed perspective and guidance on its marketing, sales and promotional activities and what practices may raise a “red flag” with both federal and state agencies. Building upon the framework established by the Code, the Office of the Inspector General (OIG) issued a body of voluntary guidelines, Compliance Program Guidance for Pharmaceutical Manufacturers, to reinforce OIG’s views on the fundamental elements of pharmaceutical manufacturer’s compliance programs and principles that should be taken into account when creating and implementing an effective compliance program, as well as to serve as a benchmark for those companies with existing programs. With this publication, the Industry must now be proactive and diligent to maintain compliance in any of its public endeavors.

Pharmaceutical Education Associates is proud to present, OIGÂ’s New Compliance Program Guidance for Pharmaceutical Manufacturers: What YOU Need to Know, an exclusive symposium that offers a comprehensive forum discussing and explaining what is currently expected by US governing and regulatory bodies.

At this first-ever forum, hear from top experts in the country on topics including:

  • Explaining the New Guidelines: Key Areas of Potential Risk
  • The Effects of the New OIG Guidance on Common Marketing Practices for Pharmaceutical Manufacturers
  • Continuing Medical Education’s (CME) New Challenge: The Office of the Inspector General
  • The Role Politics Played in the New OIG Definitions of Illegal Kickbacks and Other Remuneration
  • Medical Affairs and Publications: Getting the Message Right the Correct Way
  • Does Pharmaceutical Sponsorship Influence Science? Approaches to Funding Scientific Communications in the Age of the OIG Guidance
  • Aligning with Pharmaceutical Benefit Managers (PBMs): Formularies and Formulary Support Activities
  • The Important Role of the Compliance Committee
  • Integrity of Data Used to Establish or Determine Government Reimbursement
  • The Role of Medical Affairs in Delivering Regulatory Guidelines for Product Promotion to a Sales Organization

Hear From Our Faculty of Experts:

  • Cathy Young Thomer, Esq, Special Assistant US Attorney, Eastern Division of Pennsylvania DEPARTMENT OF JUSTICE
  • Matthew W. Davis, MD, RPh, Vice President Clinical and Medical Affairs, DR. REDDYÂ’s LABORATORIES
  • Mark H. Schaffer, EdM, Vice President, Continuing Medical Education, THOMSON PROFESSIONAL POSTGRADUATE SERVICES®, a division of Thomson Physicians World
  • John F. Kamp, Esq, of Counsel, WILEY REIN & FIELDING LLP
  • Steven James, MD, MBA, Senior Director, Medical Affairs, ELAN PHARMACEUTICALS
  • Lawrence E. Liberti, RPh, MSc, RAC, President, PHARMACEUTICAL INFORMATION ASSOCIATES, LTD.
  • W. David Dawson, PhD, Global Head, Field Medical Affairs, Medical Information and Science Director, EMD PHARMACEUTICALS, INC., an associate of MERCK KGAA, Darmstadt, Germany

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